THIS REPORT CONTAINS ASSESSMENTS OF COMMODITY AND TRADE ISSUES MADE BY

USDA STAFF AND NOT NECESSARILY STATEMENTS OF OFFICIAL U.S. GOVERNMENT

POLICY

Required Report - public distribution

Date: 2/12/2019
GAIN Report Number: E19004

EU-28

Food and Agricultural Import Regulations and Standards

Report

FAIRS Annual Country Report

Approved By:
Jennifer Lappin
Prepared By:
Sophie Bolla

Report Highlights:
This report provides an overview of EU food and feed legislation currently in force for the EU. USDA
Foreign Agricultural Service (FAS) staff reviewed and updated all sections of this annual report.
Special attention should be given to the EU's new rules on novel foods, which became applicable on
January 1, 2018. Staff also updated section on country of origin labeling rules, in force since May 2018.
For ongoing updates on developments in EU food and feed legislation, check the USEU FAS website at
www.usda-eu.org.
Contents
Section I. General Food Laws ...................................................................................................... 5
Brexit ...................................................................................................................................... 5
EU-Harmonized Legislation ................................................................................................ 5
Mutual Recognition .............................................................................................................. 6
Regulations and Directives ................................................................................................... 6
Food Safety Legislation ........................................................................................................ 6
EU Institutions ...................................................................................................................... 7
Transparency......................................................................................................................... 7
“Dual Quality” Products ...................................................................................................... 7
Advisory Bodies..................................................................................................................... 7
Enforcement .......................................................................................................................... 8
Section II. Food Additive Regulations ........................................................................................ 8
A. Additives (including colors and sweeteners) ...................................................................... 9
B. Flavorings ............................................................................................................................ 10
D. Processing Aids ................................................................................................................... 10
Section III. Pesticides and Contaminants ................................................................................. 10
A. Pesticides ............................................................................................................................. 10
Endocrine Disruptors ......................................................................................................... 11
Maximum Residue Limits (MRLs): Regulation 396/2005 .............................................. 11
Import Tolerance ................................................................................................................ 11
Upcoming Review................................................................................................................ 12
Official Controls .................................................................................................................. 12
B. Contaminants ...................................................................................................................... 12
Maximum Levels ................................................................................................................. 12
Official Controls of Maximum Levels in Foodstuffs ....................................................... 14
Official Aflatoxin Controls on U.S. Products ................................................................... 14
Residues in Animals and Animal Product ........................................................................ 15
Section IV. Packaging and Container Requirements .............................................................. 15
A. Size & Content .................................................................................................................... 15
B. Packaging Waste Management ......................................................................................... 15
C. Materials in Contact with Foodstuffs ............................................................................... 16
A. General Requirements ..................................................................................................... 17
1. Compulsory Information ......................................................................................... 18
2. Warnings on Labels .................................................................................................. 19
3. Minimum Font Size ...................................................................................................... 19
4. Language Requirements .............................................................................................. 20
5. Ingredients List............................................................................................................. 21
6. Allergen Labeling ......................................................................................................... 21
7. Minimum Durability .................................................................................................... 22
8. Quantitative Ingredients Declaration (QUID) ........................................................... 22
9. Additives & Flavorings ................................................................................................ 23

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 10. Country of Origin Labeling (COOL)...................................................................... 23
11. Alcoholic Beverages .................................................................................................. 24
12. Nutrition Declaration ............................................................................................... 25
13. Gluten-Free ............................................................................................................... 26
14. Trans Fats .................................................................................................................. 26
15. Use of Stickers ........................................................................................................... 27
16. Samples ...................................................................................................................... 27
17. Checklist for Compliance with new FIC Rules ...................................................... 27
B. Other Specific Labeling Requirements .......................................................................... 29
1. Nutrition Claims.............................................................................................................. 29
2. Health Claims .................................................................................................................. 30
3. Genetically Modified Foods Labeling ........................................................................... 31
4. Organic Food Labeling ................................................................................................... 32
5. Wine, Beer and Other Alcoholic Beverages ................................................................. 33
6. Special Use Foods ............................................................................................................ 35
7. Meat Labeling.................................................................................................................. 36
8. Health and Identification Marks ................................................................................... 38
9. Fish Labeling ....................................................................................................................... 38
10. Frozen Foodstuffs.......................................................................................................... 38
11. Vertical & Product-Specific Legislation ......................................................................... 39
Section VI. Other Specific Standards ....................................................................................... 40
A. Novel Foods ......................................................................................................................... 40
B. Food from Animal Clones.................................................................................................. 41
C. Nanotechnology ................................................................................................................. 41
D. Fortified Foods .................................................................................................................. 42
E. Dietetic Foods...................................................................................................................... 43
F. Food Supplements ............................................................................................................. 43
G. Irradiated Foodstuffs........................................................................................................ 44
H. Seafood ............................................................................................................................... 44
I. Pet Food ............................................................................................................................... 44
J. Vegetarian & Vegan Foods ............................................................................................... 45
Section VII. Facility and Product Registration ........................................................................ 45
A. Facility Registration ..................................................................................................... 45
B. Product Registration .................................................................................................... 46
Section VIII. Other Certification and Testing Requirements ................................................ 46
A. Certification and Documentation Requirements ............................................................ 46
B. Inspections........................................................................................................................... 47
Section IX. Import Procedures .................................................................................................. 48
A. Union Customs Code ......................................................................................................... 48
B. Customs Clearance ............................................................................................................. 49
C. Import Duties...................................................................................................................... 49
Section X. Copyright and/or Trademark Laws ....................................................................... 51
A. Trademarks ........................................................................................................................ 51
B. Protected Geographical Indications ................................................................................. 51
APPENDIX I. GOVERNMENT REGULATORY AGENCY CONTACTS ........................ 53
APPENDIX II. OTHER IMPORT SPECIALIST CONTACTS ............................................ 55

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DISCLAIMER – The Office of Agricultural Affairs, U.S. Mission to the European Union in
Brussels, Belgium prepared this report for U.S. exporters of domestically produced food and
agricultural products. While every possible care was taken in the preparation of this report,
information provided may not be completely accurate, either because policies have changed since
its preparation or because clear and consistent information about these policies were not
available. It is highly recommended that U.S. exporters verify the full set of import requirements
with their foreign customers, who are normally best equipped to research such matters with local
authorities, before any goods are shipped. Final approval of any product is subject to the
importing country’s rules and regulations as interpreted by border officials at the time of product
entry.

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Section I. General Food Laws
The European Union (EU) currently consists of 28 Member States with approximately 500 million
consumers. EU Member States are: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and
the United Kingdom (U.K.). As of March 29, 2019, the EU will comprise 27 Member States when the
U.K .leaves the EU (see “Brexit” section below). Montenegro, the Former Yugoslav Republic of
Macedonia, Turkey, Albania and Serbia are candidates to join the EU. On July 1, 2018, the EU
celebrated the 50th anniversary of its Customs Union which gradually expanded to become the world’s
largest trading bloc. EU customs handled 16 percent of global trade in 2017.

All EU Member countries accept the “Community acquis,” i.e. the entire body of EU laws and
obligations associated with the treaties and international agreements to which the EU is a party. EU
Member States share a customs union, a single market in which goods can move freely, a common trade
policy and a common agricultural and fisheries policy.

Brexit

On March 29, 2017, the U.K. officially informed the European Council of its intent to leave the EU. It
will remain a member of the EU until March 29, 2019. Following the conclusion of a “Withdrawal
Agreement,” a transitional period will apply from “Brexit day” until December 31, 2020. In order to
prepare for all possible negotiation outcomes, the U.K. government is publishing a batch of technical
guidance documents for businesses on the implications of an exit from the EU without a Withdrawal
Agreement. On September 24, 2018, the U.K.’s Department for Environment, Food and Rural Affairs
published a guidance document “Producing and labeling food if there is no Brexit-deal.” Notices from
European Commission departments on how Brexit will affect policies and legislation, including food
safety legislation, are published on the Commission’s “Brexit Preparedness” website.

EU-Harmonized Legislation

Most but not all food legislation is harmonized at the EU level. Imported products must meet existing
Member State requirements in cases where EU regulatory harmonization is not yet complete or absent.
U.S. exporters should be aware that products not covered by EU-harmonized food law may be subject to
different national rules. The FAIRS reports prepared by the Offices of Agricultural Affairs in the EU
Member States are excellent sources of information on Member State specific requirements. These
reports can be downloaded from the FAS website at http://gain.fas.usda.gov/Pages/Default.aspx.
Regulatory and marketing information, by Member State, is available on the Foreign Agricultural
Service Europe website.

The EU has followed a dual approach in harmonizing food laws: "horizontal" legislation covering
aspects common to all foodstuffs (such as additives, labeling, hygiene, etc.) and "vertical" legislation on
specific products (e.g., wine, cocoa and chocolate products, sugars, honey, fruit juices, fruit jams, novel

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foods, etc.). U.S. exporters should be aware that products may have to comply with several pieces of
legislation. For example, wine labeling rules are set out in specific (vertical) legislation but allergen-
labeling rules, which also apply to wine, are set out in the EU’s general food labeling (horizontal)
regulation.

Mutual Recognition

Where legislation has not been harmonized at EU-level, “mutual recognition” should guarantee the free
movement of goods in the EU. Under the principle of mutual recognition, products lawfully produced
and/or marketed in one Member State should, in theory, be allowed to be marketed in any other Member
State. There is one exception to this principle: certain directives allow Member States to make
exceptions e.g. in cases where a country can prove public safety, health or environmental concerns about
a product intended for import. Regulation 764/2008 sets out the procedural requirements for denying
mutual recognition and defines the rights and obligations of national authorities on the one hand and
enterprises on the other. The Commission evaluated regulation 764/2008 and concluded that mutual
recognition is not properly functioning. In December 2017, the European Commission presented a
proposal for a new regulation on mutual recognition. For more information on the status of the
proposal, see European Parliament briefing “Mutual recognition of goods.”

Regulations and Directives

EU food legislation consists of “regulations” and “directives,” and rules for their implementation.
Directives lay down results that must be achieved but each Member State is free to decide how to
transpose directives into national law (usually within 2-3 years after adoption). Regulations do not
require transposition. They are binding in their entirety and automatically enter into force on a set date
in all Member States. Amendments to EU legislation are published in separate directives and
regulations. Consolidated texts, i.e. the consolidation of a basic legal act and subsequent amendments
into one text, are available on the European Commission’s Eurlex website. EU laws are translated into
the 24 official languages in use in the EU-28 and published in the Official Journal as soon as they are
translated. When legislation is referenced in this guide, it is implied that all further amendments also
apply. Where possible, this guide links directly to the consolidated versions of referenced EU
legislation. The Eurlex website (http://eur-lex.europa.eu/en/index.htm) provides free access to European
Union law.

Food Safety Legislation

The EU’s “Farm to Fork” approach to food safety includes all sectors of the food and feed chain.
General Food Law regulation 178/2002 lays down the general principles, including the precautionary
principle, and sets out requirements and procedures related to food safety and crisis management. The
Member States are responsible for carrying food controls in order to check that food business operators
comply with EU food law requirements. A new regulation on harmonized food controls, regulation
2017/625, will become applicable on December 14, 2019, repealing current regulation 882/2004. A
“rapid alert system” for food and feed (RASSF) is in place to share cross-border information when risks
to public health are detected in the food chain. The Standing Committee on Food and Feed (PAFF),
composed of Member State technical experts, assists the Commission in the preparation of food and feed
safety measures. The General Food Law regulation also provided for the establishment of the European
Food Safety Authority (EFSA), an independent body that provides scientific advice to the European

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Commission. The regulations on general food law, food and feed controls, food and feed hygiene make
up the body of the EU’s food safety laws. Revisions of existing EU food regulations or new regulations
all apply the principles contained in these framework regulations. For more information, see
http://www.usda-eu.org/topics/food-safety/.

In January 2018, the Commission finalized a “fitness check” of General Food Law regulation 178/2002.
It found that ineffective risk communication has a negative impact on consumers’ trust and on the
acceptability of risk management decisions. In April 2018, the Commission presented a proposal to
revise General Food Law regulation 178/2002. The proposal aims to enhance risk communication by
creating a public EU register of studies commissioned by business operators in order to obtain an
authorization under EU food law for GMO’s, novel foods, food and feed additives, plant protection
products and food contact materials. The proposal is going through the legislative procedure and is
expected to be adopted by mid-2019. For more information, please see GAIN Report E18037 on
“Proposed New Rules on Transparency and Risk Communication”.

EU Institutions

There are three main institutions involved in developing policies and passing legislation that applies
throughout the EU: the European Commission, the Council of the European Union and the European
Parliament. In principle, the Commission proposes new laws and the Council and European Parliament
adopts them under the “Ordinary Legislative Procedure” (ex co-decision). Detailed information on the
EU procedures can be found in GAIN report “How the EU works – 2017 guide to EU decision-making”
and on our website at http://www.usda-eu.org/eu-basics-questions/.

Transparency

In March 2017, the Commission launched a single web portal where citizens and stakeholders can
provide feedback on all initiatives throughout the law-making process. The “REFIT” program, launched
in 2013, evaluates whether existing legislation is still fit for purpose and makes changes where needed.
Information on the Better Regulation Package and the REFIT program is available on the European
Commission’s website https://ec.europa.eu/info/law/law-making-process/better-regulation-why-and-
how_en.

“Dual Quality” Products

In 2017, three EU Member States - Hungary, Slovakia and Czech Republic - reported that many
products, including food products, sold in their countries are of lower quality than the same brands and
packaging sold in “older” Member States. In order to tackle this issue, the European Commission has
proposed an amendment to Directive 2005/29/EC concerning unfair business-to-consumer commercial
practices. For detailed information see GAIN report “EC Tackles Dual Quality of Foodstuff in the EU.”

Advisory Bodies

EFSA is responsible for providing scientific advice to the legislators on matters related to food safety.
EFSA’s “Applications Helpdesk” assists with the submission and monitoring of applications for

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regulated products in the following areas: animal by-products, decontamination substances, feed
additives, food contact materials, food ingredients, food processing, agricultural biotechnology products,
nutrition and pesticides. For more information, see
http://www.efsa.europa.eu/en/applicationshelpdesk.htm.

The “European Group on Ethics in Science and New Technologies” (EGE) is an independent and multi-
disciplinary advisory body tasked to advise the European Commission on ethical aspects of science and
new technologies in preparation of new EU legislation and policies. For more information, see the
European Political Strategy Centers’ website https://ec.europa.eu/research/ege/index.cfm.

Enforcement

Member State officials enforce EU food legislation. European Commission officials oversee auditing
oversight of Member State performance. The European Commission has the power to initiate legal
action in the European Court of Justice against Member States who are not complying with EU
Directives and Regulations. For more information, see the Commission’s website
https://ec.europa.eu/info/law/law-making-process/overview-law-making-process/applying-eu-
law/monitoring-implementation-eu-directives/infringement-procedure_en.

See our website

www.usda-eu.org
for updates on EU food laws and policies

Section II. Food Additive Regulations

http://www.usda-eu.org/trade-with-the-eu/eu-import-rules/food-additives/

The EU’s “Package on Food Improvement Agents” includes four Regulations: Regulation 1331/2008
establishing a common authorization procedure for food additives, food enzymes and food flavorings,
Regulation 1332/2008 on food enzymes, Regulation 1333/2008 on food additives and Regulation

8
1334/2008 on flavorings. Only additives included in the EU’s positive list may be used in food products
marketed in the EU. Inclusion in the EU positive list is based on a risk assessment by the European
Food Safety Authority (EFSA). Commission Implementing Regulation 234/2011 explains in detail how
applications to update the EU positive lists should be drafted (content, data requirements and
presentation). EFSA then verifies the suitability of the data.

A. Additives (including colors and sweeteners)

Annex II to Food Additives Regulation 1333/2008 lists all additives approved for use in foods and their
conditions of use. The authorized uses of additives are listed according to the category of food to which
they may be added. Annex I to regulation 1333/2088 lists the definitions of 26 different categories of
food additives. Only additives included in the EU’s positive list are authorized under specific
conditions. An important difference from U.S. legislation is that the EU does not allow the use of flour
beaching agents, chlorine, bromates and peroxides.

Annex III to Regulation 1333/2008 contains a second list of food additives approved for use in food
ingredients such as other food additives, food enzymes, food flavorings and nutrients. Commission
Regulation 231/2012 sets out specifications for food additives listed in Annexes II and III.

Member States may continue to prohibit the use of certain categories of food additives in traditional
foods listed in Annex IV to regulation 1333/2008.

In 2016, EFSA completed a re-evaluation of EU-approved food colors. As a result, Annex V to

Regulation 1333/2008 was amended to introduce mandatory labeling information for six food colors:
Quinoline Yellow (E104), Sunset Yellow (E110), Ponceau 4R (E124), Tartrazine (E102),
Azorubine/Carmoisine (E122) and Allura Red AC (E129). Foods containing these colors have to be
labeled “may have an adverse effect on activity and attention in children” (see also Section V – Labeling
Requirements). Commission Regulation 232/2012 lowered the limits for food colors Quinoline Yellow
(E104), Sunset Yellow (E110) and Ponceau 4R (E124). Food color Red 2G (E 128) was removed from
the EU’s positive list.

The Commission’s food additives database together with its user guide provides detailed information on
the different food additives allowed in the EU. More information on the use of food additives can be
obtained from the European Commission’s website at
https://ec.europa.eu/food/safety/food_improvement_agents/additives_en.

Re-Evaluation Program

Commission Regulation 257/2010 sets out a re-evaluation program for EFSA to assess food additives
that were approved before Food Additives Regulation 1333/2008 entered into force.

The re-evaluation of approved food additives is scheduled to be completed by the end of:

 2015 for food colors

 2015-2016 for preservatives, antioxidants, glutamates, silicon dioxide

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  2018 for all additives other than colors and sweeteners

 2020 for all sweeteners

B. Flavorings

Regulation 1334/2008 establishes a list of authorized flavoring substances, listed according to the
category of food to which they may be added. It also sets specific rules for the use of the term “natural.”
An on-line database allows consumers, food businesses and food control authorities to verify which
flavoring substances are authorized in food.

Commission Regulation 873/2012 concerns transitional measures for other flavorings such as flavorings
made from non-food sources.

Regulation 2065/2003 establishes a safety assessment and authorization procedure for smoke flavorings
intended for use in or on foods. Commission implementing Regulation1321/2013 establishes the EU
positive list of authorized smoke flavoring primary products for use as such in or on foods and/or for the
production of derived smoke flavorings.

C. Enzymes

Regulation 1332/2008 on food enzymes introduced harmonized rules for their scientific evaluation and
authorization in the EU. Articles 10-13 of Regulation 1332/2008 set out specific labeling requirements.
EFSA is currently evaluating industry applications for authorization of existing and new food enzymes.
Until the Commission draws up an EU-list of authorized food enzymes, national rules will continue to
apply. For detailed information, see the European Commission’s website
https://ec.europa.eu/food/safety/food_improvement_agents/enzymes/eu_rules_en.

D. Processing Aids

Processing aids are subject to Member States’ national legislation. EU harmonized rules exist only for
extraction solvents used in the production of foodstuffs and food ingredients (Council Directive
2009/32/EC).

Section III. Pesticides and Contaminants

A. Pesticides
http://www.usda-eu.org/trade-with-the-eu/eu-import-rules/pesticides/

European Parliament and Council Regulation 1107/2009 sets out rules for the authorization of plant
protection products (PPPs). PPPs (also referred to as 'pesticides') contain at least one approved active
substance. Only PPPs containing active substances included in the list of approved active substances as
established in Commission implementing Regulation 540/2011 may be authorized for use in the EU.
Before any PPP can be placed on the market or used, it must be authorized in the relevant Member

10
State(s). According to Annex I of Regulation 1107/2009, the EU is divided in three different zones.
Once a Member State approves the PPP, it can be mutually recognized and thus authorized within the
EU. Maximum Residue Levels (MRLs) for substances that are not on the EU positive list will be set at
default level of 0.01 mg/kg. The legislation allows exporters to request an "import tolerance" for active
substances not yet evaluated or in use in the EU.

Directive 2009/128 on the sustainable use of pesticides is also part of the so-called Pesticides Package.
For more information see the European Commission website
http://ec.europa.eu/food/plant/pesticides/sustainable_use_pesticides/index_en.htm.

Endocrine Disruptors

“Endocrine disruptors” (EDs) refer to substances with the potential to alter and cause unintentional
adverse health effects to the endocrine systems of humans and wildlife. Both the Plant Protection
Products Regulation 1107/2009 (Pesticides) and the Biocidal Products Regulation 528/2012 (Biocides)
introduced “endocrine disrupting properties” as one of the categories of hazard-based cut-off criteria.
This allows the EU to ban certain products from the market based on hazard identification rather than
risk assessment without taking exposure into account. The Commission published Regulation 2018/605,
identifying endocrine disrupting properties under Regulation 1107/2009 on plant protection products, in
the Official Journal. The criteria to identify endocrine disruptors will apply as of November 10, 2018, to
all on-going and future evaluations of active substances used in plant protection products. In June 2018,
the European Chemicals Agency (ECHA) and the European Food Safety Authority (EFSA) published a
technical guidance document to implement the criteria for both biocides and pesticides.

Maximum Residue Limits (MRLs): Regulation 396/2005

European Parliament and Council Regulation 396/2005 harmonizes all MRLs in the EU on food or feed
of plant and animal origin. Pesticide MRLs for processed or composite products are based on the MRLs
of the raw agricultural ingredients. A general default MRL of 0.01 mg/kg applies where a pesticide is
not specifically mentioned.

See the European Commission’s website at

http://ec.europa.eu/food/plant/pesticides/max_residue_levels_en for the latest updates.

For a list of authorized active substances or pesticide-MRL combinations, see the European
Commission’s online database.

In 2016, the European Commission notified a document to the WTO explaining the on-going review of
MRLs (last updated June 12, 2017) in the EU to non-EU countries, highlighting the active substances
and relevant MRLs that are scheduled to be reviewed in the near future. It also refers to the EFSA
progress report for the Article 12 review of MRLs (last updated January 15,2019).

Import Tolerance

If there is no EU legislation in place in the importing Member State, then the exporter can seek to obtain
an "import tolerance" for active substances that have not been evaluated or used in Europe before.
Applications for import tolerances must be submitted to the “Rapporteur Member State” (RMS). The

11
Commission assigns a Member State, if no RMS exists. The RMS reviewed dossiers are evaluated by
the EFSA before being forwarded to the Commission. Information on import tolerances is available in
“Pesticide Use and Food Safety” guide published by the European Crop Protection Association (ECPA).
As of September 2, 2008 all MRLs, including import tolerances, apply EU wide. The application form
for an import tolerance can be found here.

Upcoming Review

The European Commission is currently undergoing a regulatory fitness and performance check (REFIT)
of the EU legislation on pesticides and pesticides residues. The evaluation process consists of different
steps, such as a roadmap, an external study, as well as a consultation strategy with an online public
consultation, focus groups, in-depth interview, case studies etc. in order to collect data and information.
The external evaluation study was published on October 18, 2018, including an executive summary.
The final report concluding the REFIT of the EU pesticide legislation is expected in the first half of
2019.

In addition to the Commission’s evaluation, the European Parliament formed a special Committee on
Pesticides that has to investigate glyphosate and other pesticide products. The PEST Committee adopted
its report on December 6, 2018. The file still needs go to through the European Parliament plenary in
January 2019. Some of the recommendations from the PEST report will also be of use for the final
REFIT report.

Official Controls

Harmonized sampling methods are established for the official control of residues in and on products of
plant and animal origin by Commission Directive 2002/63/EC. Commission Implementing Regulation
2018/555 outlines the latest version of the coordinated multi annual control program of the EU for
pesticides residues, which requires Member States to take and analyze samples for product and pesticide
residue combinations in food of plant and animal origin. Annex I to the Regulation sets out the pesticide
and product combinations to be monitored. Annex II sets out the number of samples that need to be
taken for each combination. The Member States must submit results of the sample tests to the EU by 31
August 2020, 2021 and 2022 for samples tested in 2019, 2020 and 2021 respectively. For more
information, see the European Commission website
http://ec.europa.eu/food/plant/pesticides/max_residue_levels/enforcement/index_en.htm.

B. Contaminants
http://www.usda-eu.org/trade-with-the-eu/eu-import-rules/contaminants/

Maximum Levels

EU- wide harmonized maximum levels for contaminants are set in the Annex of Commission Regulation
1881/2006. The Annex to Regulation 1881/2006 includes maximum levels for:

 Nitrates in lettuce, spinach and infant food (section 1)

 Mycotoxins (section 2):

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 o aflatoxins in nuts, dried fruit, cereals, maize, spices, milk and infant food
o ochratoxin A in cereals, cereal products, dried vine fruit, roasted coffee, soluble coffee, wine,
grape juice, spices, infant food and licorice
o patulin in fruit juices, spirit drinks, solid apple products, apple juice and infant food
o deoxynivalenol in cereals, cereal products, maize, pasta and infant food
o zearelenone in cereals, cereal products, maize, refined maize oil, bread and small bakery
wares and infant food
o fumonisins in maize and maize based products
o T-2 and HT-2 toxin in cereals and cereal products
o citrinin in rice/yeast fermented food supplements
o ergot sclerotia and ergot alkaloids

Please note that the EU is also expected to restart the discussion on the expansion of the group of
products subject to a maximum level for ochratoxin A.

 Heavy metals (section 3):

o lead in milk, baby and infant food, meat, offal, seafood, vegetables, fruit, wine and food
supplements
o cadmium in meat, fish and seafood, cereals, soybeans, vegetables, fruit, fungi and food
supplements, baby formula and infant food, cereals and soybeans, cocoa
o mercury in seafood and food supplements
o tin in canned foods, canned beverages and canned baby foods

 3-monochloropropanediol (3-MCPD) and glycidyl fatty acid esters (section 4)

o 3-MCPD in vegetable protein and soy sauce
o Glycidyl fatty acid esters expressed as glycidol in fats and oils and infant formula

 Dioxin and PCBs in meat, liver, fishery products, milk, eggs and oils & fats (section 5)
Please note that the EU is expected to start discussions on the lowering of the maximum levels of
dioxins following the lowering of the tolerable weekly intake (TWI) by the European Food
Safety Authority in November 2018.

 Polycyclic aromatic hydrocarbons (PAH) in oils & fats, cocoa, infant foods, (smoked) meat,
bivalve mollusks, fish and infant food (section 6)
 Melamine in infant food (section 7)
 Inherent plant toxins (section 8):
o erucic acid in fats and oils, foods containing these ingredients and infant formula
o tropane alkaloids in processed cereal-based foods
o hydrocyanic acid in apricot kernels

In November 2017, the EU adopted a Regulation 2017/2158 establishing benchmark levels to reduce the
presence of acrylamide in food. The new regulation requires that food business operators apply
mandatory measures to reduce the presence of acrylamide, proportionate to the size and nature of their
establishment. The Commission is monitoring the acrylamide issue with stakeholders with the view to
initiate discussions on additional measures, such as setting maximum levels of acrylamide in certain
13
foods.

For additional information on acrylamide levels in food, see:

 http://www.fooddrinkeurope.eu/publication/Download-FoodDrinkEurope-Acrylamide-
Pamphlets-in-23-languages/

 https://ec.europa.eu/food/safety/chemical_safety/contaminants/catalogue/acrylamide_en

Official Controls of Maximum Levels in Foodstuffs

The following regulations concern the sampling methods and methods of analysis for the official
controls of the levels of the different contaminants. Annex I describes the methods of sampling; Annex
II concerns the sample preparation and the performance criteria for the methods of analysis:
 Nitrates: Commission Regulation 1882/2006
 Mycotoxins: Commission Regulation 401/2006
 Dioxins: Commission Regulation 2017/644
 Heavy metals, Tin, 3-MCPD and benzo(a)pyrene: Commission Regulation 333/2007
 Erucic acid: Commission Regulation (EU) 2015/705

Official Aflatoxin Controls on U.S. Products

In April 2015, the EU approved the pre-export checks (PEC) program for U.S. almonds. U.S. almonds
were included in the Annex to Commission Implementing Regulation (EU) 2015/949, which lists all
EU-approved Pre-export Check programs. The acceptance of the U.S. program reflects the EU’s
recognition of aflatoxin controls performed at U.S. origin in line with Article 23 of the EU Regulation
on Official Food and Feed Controls (Regulation (EC) No 882/2004). The latter regulation, which
provides the general framework for food controls, will be replaced by Regulation (EU) 2017/625 of the
European Parliament and of the Council from Dec 15, 2019 onwards. The USDA Agricultural
Marketing Service began issuing PEC almond certificates on August 1, 2015. The almond PEC
program builds on and replaces the Voluntary Aflatoxin Sampling Plan (VASP) program, which was no
longer required after September 2014 when the EU voted to remove California Almonds from Special
Measures.

Following the publication of Commission Implementing Regulation (EU) 2017/1269 on July 14, 2017,
the U.S. pre-export program for peanuts is no longer recognized by the EU. There is no restriction on
the export of U.S. peanuts; however, shipments are no longer benefitting from the reduced testing
level for aflatoxin upon entry into the EU.

On April 1, 2015, U.S. pistachios were included in the list of products/origins subject to increased
import controls under Commission Regulation (EC) No 669/2009. Member States must now test 10
percent of all incoming shipments. This regulation does not impose any requirements on exporters.

For additional information on aflatoxin testing and certification performed in the United States prior to
export to the EU, see:
 http://www.almonds.com/sites/default/files/pec_program_manual_version_9.0.pdf

14
  http://www.peanutsusa.org.uk/eu-food-aflatoxin-legislation
 http://www.ams.usda.gov/services/lab-testing/aflatoxin

Residues in Animals and Animal Product

http://www.usda-eu.org/trade-with-the-eu/eu-import-rules/certification/residue-plans/

The monitoring of residues in animals and animal products is addressed separately in Council Directive
96/23/EC. This directive includes the monitoring of pesticide residues as well as residues of veterinary
drugs and a wide range of other contaminants and undesired substances such as residues of growth
promotants. The prohibition of the use of hormones in meat production is addressed in Council
Directive 96/22/EC. Directive 96/23/EC states that any third country exporting to the EU must submit a
plan setting out its guarantees on the monitoring of the groups of residues and substances referred to in
Annex I to Council Directive 96/23/EC. Furthermore, a split system has to be in place guaranteeing that
animals have not been treated with growth promotants if their products will be exported to the EU.

For additional information on how to export food of animal origin to the EU, see:
 Imports of food of animal origin from non-EU countries: Provisions of guarantees equivalent to
EU requirements on residues of veterinary medicines, pesticides and contaminants

Section IV. Packaging and Container Requirements

A. Size & Content

The maximum tolerable error between the actual content weight and the quantity indicated on the label,
and methods to check this are fixed in Council Directive 76/211/EEC, as amended. A small "e" of at
least 3 mm on the label guarantees that the actual content corresponds to the quantity indicated. The
size of the figures indicating the quantity depends on the nominal quantity:
 nominal quantity greater than 1000 g or 100 cl: at least 6 mm high
 greater than 200 g/20 cl but less than 1000 g/100 cl: at least 4 mm
 greater than 50 g/5 cl but less than 200 g/20 cl: at least 3 mm
 less than 50 g/2 cl: 2 mm. The quantity must be followed by the unit of measurement.

Directive 2007/45/EC abolished regulations on mandatory pack sizes at both EU and national levels.
Under this Directive, only wine and spirits and coffee have defined package sizes. Mandatory nominal
quantities for wines and spirits are set out in the Annex to Directive 2007/45/EC.

Detailed information on “Legal Metrology” is available on the European Commission’s website

http://ec.europa.eu/growth/single-market/goods/building-blocks/legal-metrology/.

B. Packaging Waste Management

Member States are required to take measures to reduce packaging waste and must introduce systems for

15
reuse, recovery and recycling of packaging materials. Council Directive 94/62/EC provides for
measures aimed at limiting the production of packaging waste and promoting recycling, re-use and other
forms of waste recovery. A well-known and widely used recycling program is the German “green dot”
system. More information can be found on the Packaging Recovery Organization Europe website,
which provides easy access to all Green Dot systems in Europe (www.pro-e.org). An overview of
current EU legislation applicable to packaging and packaging waste is available on the European
Commission’s website http://ec.europa.eu/environment/waste/packaging/legis.htm.

C. Materials in Contact with Foodstuffs

European Parliament and Council Regulation 1935/2004 specifies the main requirements for all
materials that come into contact with foodstuffs. It also sets out labeling and traceability requirements
and the procedure for the authorization of substances through the European Food Safety Authority
(EFSA). Annex I to regulation 1935/2004 lists the group of materials, which may be covered by
specific measures.

The European Commission is currently undergoing a regulatory fitness and performance check (REFIT)
of the EU's Food Contact Material's (FCM) legislation. The evaluation process consists of different
steps, including a 12-week open public consultation foreseen in late 2018 as part of the stakeholder
consultation process. FAS anticipates that the Commission will complete the evaluation in early 2020.

Commission Regulation 2023/2006 lays down rules on good manufacturing practice (GMP) for the
groups of materials and articles intended to come into contact with food listed in annex I to Regulation
1935/2004.

Specific measures set out additional requirements and include lists of authorized substances and
materials. To date, specific directives have been developed for plastic materials (Commission
Regulation 10/2011), including a union list of authorized substances. There is an EU guidance
document available on its implementation. Commission Implementing Regulation 321/2011, amending
Regulation 10/2011 on plastic materials, bans the use of Bisphenol A in plastic infant feeding bottles,
while Commission Regulation (EU) 2018/213 is limiting the use of bisphenol A in varnishes and
coatings intended to come into contact with food.

Another specific measure is set out in Commission Regulation 450/2009 sets out definitions and
authorization procedures for the use of active and intelligent materials and articles intended to come into
contact with food. An EU guidance document on active and intelligent food contact materials is
available on the European Commission’s website.

There are also the recycled plastic materials (Commission Regulation 282/2008), regenerated cellulose
film (Commission Directive 2007/42/EC) and ceramics (Council Directive 84/500/EC). In the case of
ceramics, migration limits have been established for lead and cadmium. Materials must bear an
indication "for food contact" or the symbol reproduced in Annex II to Regulation 1935/2004.

Member States are allowed to authorize provisionally the use of certain substances not listed in one of
the specific directives. They may also restrict or temporarily prohibit the use of certain materials

16
authorized by the specific directives for reasons of public health. When there is no specific EU
legislation, Member States may establish national measures. U.S. exporters are advised to verify if
Member State specific measures apply. A summary of EU and national legislation as well as guidance
documents and contact information with regard to the submission of applications for authorization can
be downloaded from the European Commission website at
http://ec.europa.eu/food/safety/chemical_safety/food_contact_materials_en.

In May 2018, the European Commission proposed new rules to target the ten single use plastic products
most often found on Europe’s beaches and seas, as well as lost fishing gear. The ban of certain products
could also affect food packaging in the future. For more information:
https://ec.europa.eu/commission/news/single-use-plastics-2018-may-28_en

For more information see the European Commission’s brochure on Food Contact
Materials

Section V. Labeling Requirements

A. General Requirements

The standard U.S. label fails to comply with EU labeling requirements. On December 13, 2014, the
EU’s “Food Information to Consumers (FIC)” regulation 1169/2011 became applicable to all pre-
packaged food and drink products marketed in the EU, including those imported from third countries.
The mandatory nutrition declaration requirement introduced by the FIC regulation became applicable on
December 13, 2016.

Detailed information on food labeling requirements set out in the FIC regulation is available in GAIN
report “New EU Food Labeling Rules Published”, supplemented by GAIN report “How to Comply with
the EU’s New Food Labeling Rules”. These reports as well as updates on EU labeling rules can be
found on FAS USEU’s website at http://www.usda-eu.org/trade-with-the-eu/eu-import-rules/eu-
labeling-requirements/.

In order to assist food business operators complying with the EU’s food labeling rules, the European
Commission as well as several Member State authorities and EU food federations have published
guidance documents.

 European Commission: Questions and Answers on the Application of Regulation 1169/2011 on

the Provisions of Food Information to Consumers (January 2013)

 European Commission: Notice on questions and answers on the application of Regulation

1169/2011 on the Provision of Food Information to Consumers (June 2018)

 European Commission: Infographic on the new labeling rules

17
  FoodDrink Europe (EU Food and Drink Industry Confederation): Guidance on the Provision of
Food Information to Consumers

 U.K.: Food Labeling – Giving food information to consumers

The objective of a “regulation” is to set harmonized rules that apply throughout the EU. However, the
FIC regulation allows EU Member States to deviate from EU rules. Article 39 of the FIC regulation sets
conditions for Member States to adopt additional mandatory national measures, including measures for
country of origin labeling. The FIC regulation exempts alcoholic beverages from mandatory nutrition
labeling and ingredient listing but Article 41 allows Member States to maintain national rules on the
listing of ingredients until EU-harmonized provisions are adopted. U.S. exporters are strongly advised
to check for additional national requirements with their importers.

In June 2018, the European Commission published additional guidance on the

application of the FIC.

1. Compulsory Information

Article 9 of FIC regulation 1169/2011 sets out the list of mandatory declarations on food and drink
labels:

 Name of the food

 List of ingredients

 Allergens listed in Annex II

 Quantity of certain ingredients or category of ingredients

 Net quantity of the food

 Date of minimum durability or “use by date”

 Any special storage conditions and/or conditions of use

 Name of business name and address of the food business operator under whose name the
food is marketed. If that operator is not established in the EU, the name and address of the
importer

 Country of origin or place of provenance in accordance with the provisions of Article 26

18
  Instructions for use where it would be difficult to make appropriate use of the food in the
absence of such instructions

 Alcoholic strength by volume for beverages containing more than 1.2% by volume of alcohol

 Nutrition declaration

2. Warnings on Labels

Annex III to FIC regulation 1169/2011 establishes a list of products that require a special warning on the
label:

 Foods whose durability has been extended by means of packaging gases

 Foods containing sweeteners authorized under Food Additives Regulation 1333/2008

 Foods containing added sugar and sweeteners authorized under Food Additives Regulation
1333/2008

 Foods containing aspartame authorized under Food Additives Regulation 1333/2008

 Foods containing more than 10% added polyols authorized under Food Additives
Regulation 1333/2008

 Confectionery and beverages containing licorice (glycyrrhizinic acid or its ammonium salt)
 Beverages containing more than 150mg/l of caffeine and foods with added caffeine
 Foods or food ingredients with added phytosterols, phytosterol esters, phytostanols or
phytostanol esters

Annex V to Food Additives Regulation 1333/2008 requires foodstuffs containing the food colors sunset
yellow (E110), quinoline yellow (E104), carmoisine (E122), allura red (E129), tartrazine (E102) and
ponceau 4R (E124) to be labeled “may have an adverse effect on activity and attention in children.”

Any non-edible parts of a packaging system that consumers could mistake for food must be labeled with
the words “DO NOT EAT” and where technically possible carry a warning symbol.

3. Minimum Font Size

Article 13 of FIC regulation 1169/2011 introduces a minimum font size for printing the mandatory
information on food and drink labels. As a general rule, the information must be printed in characters
using of minimum font size of 1.2 mm for the “x-height” as defined in Annex IV. If the largest surface
of a food package or container is less than 80 cm2, the minimum font size is reduced to 0.9 mm. On
packages with a printable surface smaller than 25 cm2, the nutrition declaration is not required.
Packages which are smaller than 10 cm2 do not need to bear a nutrition declaration nor a list of
ingredients.

19
The minimum font size does not apply to mandatory labeling requirements set out in other EU
legislation such as for example the font size requirements set out in Directive 76/2011 to indicate the
nominal quantity (see Section IV Packaging and Container Requirements).

Minimum Font Size for printing mandatory information is 1.2 mm

4. Language Requirements

Article 15 of FIC regulation 1169/2011 stipulates that the mandatory information should be provided in
“a language easily understood by the consumers of the Member States where the food is marketed.” In
practice, this means the official language(s) of that Member State. Member States may specify which
information needs to be provided in one or more official EU languages. In order to avoid non-
compliance with the new labeling rules, translations of mandatory information must be accurate.
Automated online translation tools may generate incorrect translations and should not be used unless
edited. Please consult the Member State FAIRS reports for information on specific Member State
language requirements.

20
 U.S. Exporters should verify with their importers about additional Member
State language requirements

5. Ingredients List

The word “ingredients” must precede the list of ingredients. All ingredients must be designated by their
specific name and listed in descending order of weight. Ingredients present in the form of engineered
nanomaterials must be indicated in the list of ingredients followed by the word “nano” in brackets.
Annex VII to FIC regulation 1169/2011 sets out specific provisions concerning the indication of
ingredients and categories of ingredients in the list of ingredients. This Annex requires the mandatory
indication of the source of vegetable oils and fats.

In the list of ingredients “Vegetable oils” and “vegetable fats” must be followed
by a list of the specific vegetable sources

6. Allergen Labeling
http://www.usda-eu.org/trade-with-the-eu/eu-import-rules/eu-labeling-requirements/allergen-labeling/

FIC regulation 1169/2011 introduced important changes for allergen labeling. Article 21 of the FIC
regulation stipulates that each product or substance capable of inducing an allergic reaction must be
indicated in the list of ingredients with reference to the name of the substance or product as listed in
Annex II to the FIC regulation. The name of the substance or product must be highlighted through a
typeset that clearly distinguishes it from the other ingredients, for example in bold or with a background
color.

Example: “tofu” (soya) – “whey” (milk)

Where an ingredients list is provided, the voluntary use of warning boxes or statements such as
“contains X” to repeat the presence of the allergenic ingredients is no longer allowed.

On products that do not require an ingredients list, such as for example wine, the presence of allergens
must be indicated using the word “contains” followed by the name of the substance or product as listed
in Annex II to the FIC regulation. Allergen labeling is mandatory on all alcoholic beverages and must
respect the minimum font size requirement. Member States may decide in which language(s) allergens
should be indicated on the label.

21
Following a public consultation launched in November 2014, the Commission published an update of its
guidance document on allergen labeling in July 2017.

Other guidance documents:

 Allergen Labeling – Annex 3 (FoodDrinkEurope)

 Advice on Food Allergen Labeling (U.K. Food Standards Agency)
 Food allergen labeling – technical guidance (U.K. Food Standards Agency)
 Allergen Labeling – Food Safety Authority Ireland

Allergens must be highlighted in the list of ingredients

7. Minimum Durability
http://www.usda-eu.org/trade-with-the-eu/eu-import-rules/eu-labeling-requirements/shelf-life/

Annex X to FIC regulation 1169/2011 sets out rules for the indication of the date of minimum durability,
use-by date and date of freezing. The use-by date must be indicated on individual pre-packed portions.
The durability date AND the date of (first) freezing preceded by the words “frozen on” is required on
labels of frozen meat, frozen meat preparations and frozen unprocessed fishery products.

Dates must be given in the following order: day/month/(if required) year

8. Quantitative Ingredients Declaration (QUID)

http://www.usda-eu.org/trade-with-the-eu/eu-import-rules/eu-labeling-requirements/quantitative-
ingredients-declaration/

Article 22 of the FIC regulation requires the indication of the quantity of an ingredient or category of
ingredients in the following cases:

 Where the ingredient or category of ingredients appears in the name of the food or is usually
associated with that name by the consumer

 Where the ingredient or category of ingredients is emphasized on the labeling in words, pictures
or graphics

 Where the ingredient or category of ingredients is essential to characterize a foodstuff and to

distinguish it from similar products

22
The QUID declaration, expressed as a percentage, must appear either in or immediately next to the name
of the food or in the list of ingredients. Annex VIII to the FIC regulation sets out the technical rules and
exemptions from the QUID requirement.

In November 2017, the European Commission published updated guidelines on the QUID requirement
in Official Journal C 393. The guidelines explain when QIUD is mandatory and which products are
exempt from QUID.

If an ingredient is emphasized on the label, the quantity (%) must be indicated

in the list of ingredients

Example: “made with butter” – QUID for butter

9. Additives & Flavorings

Annex VII, Part C to FIC regulation 1169/2011 lists the categories of additives, which must be
designated by the name of their category, followed by their specific name or E-number. Part D of the
same Annex sets out rules for the indication of flavorings, smoke flavorings and the use of the term
“natural.”

10. Country of Origin Labeling (COOL)

http://www.usda-eu.org/trade-with-the-eu/eu-import-rules/eu-labeling-requirements/country-of-origin-
labeling/

Before the adoption of FIC Regulation 1169/2011 COOL was already mandatory for honey, fruit and
vegetables, olive oil, fishery and aquaculture products and beef. The FIC regulation extends the
mandatory COOL requirement to fresh, chilled and frozen pork, sheep and goat meat and poultry.
Under Article 26 of the FIC regulation, mandatory COOL applies in the following cases:

 Where failure to indicate the country of origin or place of provenance might mislead the
consumer

 For fresh, chilled and frozen pork, sheep and goat meat and poultry (see “Meat Labeling”)

On May 29, 2018, the European Commission published Implementing Regulation 2018/775, which
introduces mandatory dual origin labeling when a country of origin is given or visually implied on the
label of a food product but the origin is not the same as that of its primary ingredient. Producers can
simply state that the main ingredient does not originate from the country origin if the food or label is as
“EU,” “non-EU”, the name of a third country or any other option listed in Article 2 of the Regulation.
This Regulation will enter into force on April 1, 2020. The European Commission is required to publish
a guidance document at least 6 months before this date. More information can be found in the GAIN

23
report “Commission Briefing on New Origin Labeling Rules”

Example: A jar of peanut butter with a statement such as “made in the USA” or carrying an American
flag would trigger this regulation if the peanuts were sourced from another country.

Detailed information on COOL is provided in GAIN report “The EU’s Country of Origin Labeling
Policy” and on the FAS/USEU website http://www.usda-eu.org/trade-with-the-eu/eu-import-rules/eu-
labeling-requirements/country-of-origin-labeling/. The FIC regulation required the European
Commission to prepare reports on the feasibility of introducing mandatory COOL for dairy products,
“minor” meats, unprocessed products and single ingredient products. The reports are available on DG
SANTE’s website http://ec.europa.eu/food/safety/labelling_nutrition/labelling_legislation/index_en.htm.

COOL is mandatory for honey, fruit and vegetables, olive oil, fishery and
aquaculture products, beef, pork, sheep and goat meat and poultry

11. Alcoholic Beverages

Alcoholic beverages containing more than 1.2% of alcohol by volume are still exempted from the
obligation to bear a nutrition declaration and a list of ingredients. The FIC regulation required the
European Commission to prepare a report by end 2014 examining whether the exemption for alcoholic
beverages should be maintained. In March 2017, the Commission finally published its long awaited
report. Following the conclusions of the report, the Commission gave the EU alcoholic beverages
industry one year to present a self-regulatory proposal covering all beverages (beer, wines and spirits).
In March 2018, the industry presented a joint self-regulatory proposal outlining general principles of a
labeling scheme shared by the alcoholic beverage industry. These general principles are accompanied by
four sector sector-specific implementation plans for wine, spirit drinks, beer and cider & fruit wine. The
European Commission is still assessing the proposal. It is unclear if the current Commission will take a
decision on whether or not putting forward a legislative proposal before the end of its term in May 2019.
It is likely that the new Commission will decide if this is a priority or not when it takes office in
November 2019. More information is available in GAIN report “EU Alcohol Industry Labeling Proposal
– Labeling Apart Together”.

Allergen labeling is compulsory on all alcoholic beverages (see “Allergen Labeling”). On beverages
containing more than 1.2% of alcohol by volume (excluding wines), the actual alcoholic strength by
volume must be indicated in accordance with Annex XII to FIC regulation 1169/2011. The alcoholic
strength must be indicated by a figure with maximum one decimal place followed by the symbol “%
vol.” The alcoholic strength must be given in the same field of vision as the product name and the net
quantity. For wines, rules for the indication of the alcoholic strength are set out in specific legislation
(see Chapter B.5 “Other Specific Labeling Requirements - Wine”).

24
 The alcoholic strength must be given in the same field of vision as the product
name and the net quantity

12. Nutrition Declaration

http://www.usda-eu.org/trade-with-the-eu/eu-import-rules/eu-labeling-requirements/nutritional-labeling/

Under FIC regulation 1169/2011, the nutrition declaration became mandatory on December 13, 2016.
Annex V to the FIC regulation lists foodstuffs which are exempted from the mandatory nutrition
declaration requirement. The nutrition declaration must be presented, if space permits, in tabular format
with the numbers aligned and where space does not permit, in linear format. All elements of the
mandatory nutrition declaration should be in the same field of vision on the food label or package.

Mandatory content of the nutrition declaration:

 Energy value: expressed in kilojoules (kj) and kilocalories (kcal)

 In this particular order: amounts of fat, saturates, carbohydrate, sugars, protein and salt,
expressed in grams (g), milligrams (mg) or micrograms (µg) per 100 grams or per 100 milliliters

Nutrition declarations per portion or per consumption unit, in addition to the declaration per 100 grams
or milliliters are allowed provided that the number of portions/consumption units is clearly indicated on
the package. The salt content must be expressed as “salt” not “sodium” but where appropriate, a
statement indicating that the salt content is exclusively due to the presence of naturally occurring sodium
may appear in close proximity to the nutrition declaration.

The following elements may, on a voluntary basis, be repeated on the front label:

 Energy value

 Energy value together with the amounts of fat, saturates, sugars and salt

The content of the mandatory nutrition declaration may be supplemented with the indication of the
amounts of one or more of the following:

 Monounsaturates

 Polyunsaturates

 Polyols

 Starch

 Fiber

25
  Vitamins and minerals listed in Part A of Annex III to the FIC regulation (incl. percentage of
reference intakes)

Detailed rules on the presentation of the nutrition declaration are set out in Annex XV to the FIC
regulation.

Annex V to the FIC regulation establishes a list of products that are exempted from the mandatory
nutrition declaration requirement.

The EU’s Food & Drink Industry Federation “FoodDrinkEurope” has launched a website explaining
“reference intakes” to food business operators and consumers: http://referenceintakes.eu/reference-
templates.html. For detailed information on the nutrition panel see the guidance documents listed in
“General Requirements” (Chapter A).

Article 35 of the FIC regulation allows Member States to recommend the use of additional forms of
expression or presentation of the nutrition declaration. So far, five Member States have adopted
additional nutritional labeling schemes: Sweden, Denmark, France, Belgium and the United Kingdom.
The FIC regulation required the Commission to prepare a report by December 13, 2017, on experience
gained with the national schemes, such as the U.K. traffic light labeling scheme, and the advisability of
further harmonization in this area. The Commission has not published this report yet.

Nutrition information must be presented in tabular format and in a specific

order expressed per 100 grams/milliliters

13. Gluten-Free

Harmonized compositional and labeling rules for foods for persons with gluten intolerance were
previously set out in the EU’s directive on foods for particular nutritional uses (Regulation 41/2009).
With the adoption of the new dietetic foods regulation 609/2013, it was decided that gluten-free foods
would be regulated under the FIC regulation. Commission Implementing Regulation 828/2014,
applicable since July 20, 2016, sets out conditions for using “gluten-free” and “very low gluten”
statements on food labels.

14. Trans Fats

Rules to limit and label the content of trans fats in food products are not yet EU-harmonized. Certain
Member States such as Denmark, Austria, Hungary and Latvia have set national legal limits on
industrially produced trans fats in foods. The FIC regulation required the European Commission to
prepare a report by end 2014 on the presence of trans fats in foods. On October 11, 2016, the
Commission published a roadmap to assess several policy options for limiting industrial trans fat intakes
in the EU.

26
On October 4 2018, the Commission published a draft Commission Regulation amending Annex III to
Regulation 1925/2006 on trans fat. If adopted, the new regulation would set a maximum limit of trans
fat, other than trans fat naturally occurring in animal fat, in food that is intended for the final consumer,
of 2 grams per 100 grams of fat. The legislation is expected to be adopted before Summer 2019.

15. Use of Stickers

Specific rules on the use of stickers to provide mandatory labeling information are not included in FIC
regulation 1169/2011. On this issue, the European Commission refers to point 2.1.1 of their Questions
and Answers on the Application of Regulation 1169/2011 document, which says, “labels should not be
easily removable so as to jeopardize the availability or the accessibility of the mandatory food
information to the consumer.” Some Member States may allow the use of stickers while other may not.
Please consult the Member State FAIRS reports for more information.

U.S. Exporters should check with their importers whether the destination
Member State allows the use of stickers

16. Samples

FIC Regulation 1169/2011 does not include any provisions on samples.

17. Checklist for Compliance with new FIC Rules

FOOD LABELS
Language / Specific Member State requirements
Minimum font size
Name of food (must include specific treatments such as “refrozen,” “smoked,” “powdered,”
percentage of added water to meat and fishery products
Warnings (Annex III to FIC regulation lists products that require a warning label)
Instructions for use (symbols are allowed IN ADDITION to text)

ALLERGEN LABELING
Allergens listed in Annex II to FIC regulation must be indicated

27
Allergen boxes are no longer allowed when an ingredients list is provided
Each allergen must be highlighted (bold, background color) in the list of ingredients
“Contains + name of allergen” where no ingredients list is provided

INGREDIENTS LIST
Heading must include the word “Ingredients” (do not highlight)
All ingredient must be listed in descending order of weight
“Nano” in brackets to indicate presence of engineered nanomaterials
Quantitative Ingredients Declaration (QUID) for ingredients given special emphasis
Source of vegetable oil or fat must be indicated
Proteins added to meat products must be indicated

DATE OF MINIMUM DURABILITY

Instructions listed in Annex X to FIC regulation
“Use by” date on highly perishable foods / on each individual pre-packed portion / storage
instructions
“Best before” / “Best before end” on other foods
Durability AND “frozen on” date on frozen products
Reference to where the date is given on the label

ALCOHOLIC STRENGTH
Instructions listed in Annex XII to FIC regulation
Actual alcoholic strength by volume of alcohol of beverages containing more than 1.2% by volume
of alcohol must be indicated as “alcohol” or the abbreviation “alc.” X% vol.
Product name, net quantity and alcohol strength must be indicated in the same field of vision

COUNTRY OF ORIGIN (COOL)

Mandatory COOL where failure to indicate this would mislead consumer
Mandatory COOL for meat from sheep, goats, poultry and pigs
Mandatory COOL for other products may be adopted in near future

Mandatory Nutrition Declaration (applicable as of December 13, 2016 –

nutrition panels provided before this date must comply with FIC regulation)
Instructions listed in Annex XV to FIC regulation
Tabular format (linear format where space does not permit tabular format)
Expressed per 100g/ml
Energy in KJ and kcal
In this particular order, amounts of:

28
 Fat
Saturates
Carbohydrate
Sugars
Protein
Salt (not sodium)

Voluntary Nutrition Declaration (may complement Mandatory Nutrition

Declaration)
Mono saturates
Polyunsaturates
Polyols
Starch
Fibre
Vitamins and minerals listed in Annex XIII to FIC regulation
Energy value or Energy Value together with Fats, Saturates, Sugars, Salt may be repeated
Reference Intake (RI) set out in Annex XIII per portion or consumption unit (must include energy
value per 100g/ml and per portion)

See also Commission infographic “New EU food labeling rules.”

B. Other Specific Labeling Requirements

The EU’s “Food Information to Consumers” regulation 1169/2011 sets out horizontal rules applicable to
all products. Sectoral or “vertical” legislation exists for a number of products. Labeling requirements
set out in product-specific legislation complement the horizontal rules set out in regulation 1169/2011.
For example, EU wine regulations do not include provisions on allergen labeling. This means that wine
labels not only have to comply with the requirements set out in wine regulation 607/2009 but also with
the allergen labeling requirement set out in FIC regulation 1169/2011.

U.S. Exporters should be aware that different pieces of legislation may apply to
single products

1. Nutrition Claims

The Annex to Nutrition & Health Claims Regulation 1924/2006 lists the EU authorized nutrition claims
and their conditions of use. The use of nutrition claims not included in the annex is not allowed.

29
2. Health Claims
http://www.usda-eu.org/trade-with-the-eu/eu-import-rules/nutrition-health-claims/

Rules on the use of health claims are set out in Nutrition & Health Claims Regulation 1924/2006.
Regulation 432/2012 establishes the EU positive list of functional health claims and their conditions of
use. Any producer can use the permitted health claims provided the conditions set out in Regulation
432/2012 are met. The EU’s online “Register of Nutrition and Health Claims” lists the authorized
health claims as well as the rejected claims and the reasons for their non-authorization. Since
December 14, 2012, all claims that are not authorized and not on hold or under consideration are
prohibited. Food products carrying claims must also comply with the provisions of the EU’s “Food
Information to Consumers (FIC)” regulation 1169/2011. Commission Implementing Decision 2013/63
sets out guidelines for national control authorities as regards the implementation of specific conditions
for permitted health claims.

The authorization of health claims referring to botanical substances was put on hold because of the
potential conflict with the EU’s Traditional Herbal Medicinal Products Directive. In October 2015, the
European commission published a “roadmap” to evaluate two specific elements of Regulation
1924/2006: the authorization of health claims referring to botanical ingredients and the establishment of
nutrient profiles. Regulation 1924/2006 required the Commission to establish by January 19, 2009,
thresholds for salt, fat and sugar above which nutrition and health claims would be restricted. To date,
nutrient profiles have not yet been adopted and the Commission is assessing whether they are still
necessary to ensure adequate implementation of the regulation. The outcome of the review process will
be used to decide whether the nutrition and health claims regulation should be amended.

The list of permitted functional health claims is different from the individual applications for health
claims relating to disease risk reduction and claims referring to the health and development of children,
which require an authorization on a case-by-case basis, following the submission of a scientific dossier
to EFSA. A simplified authorization procedure was established for health claims based on new
scientific data.

Regulation 353/2008 sets out implementing rules for applications for the authorization of health claims
as provided for in Article 15 of Regulation 1924/2006. GAIN Report E48055 describes how application
dossiers for authorization of health claims should be prepared and presented. A guidance document on
how companies can apply for health claim authorizations can be downloaded from EFSA’s website at
http://www.efsa.europa.eu/en/nda/ndaclaims.htm.

Commission Regulation 907/2013 establishes rules for the use of “generic descriptors” which could be
interpreted by consumers as health claims. Generic descriptors such as “digestive biscuits” and “cough
drop” would normally be banned under Regulation 1924/2006 because they suggest a beneficial effect
on health but the implied health benefit has not been evaluated scientifically by the European Food
Safety Authority (EFSA). For more information see GAIN report “Health Claims – New EU Regulation
on Generic Descriptors”.

Trademarks and brand names that suggest health and/or nutritional benefits but do not comply with the
new rules must be entirely removed from the EU market by January 19, 2022.

30
 Health Claims are only allowed if the importance of a balanced diet and healthy
lifestyle is also stated on the label

3. Genetically Modified Foods Labeling

http://www.usda-eu.org/trade-with-the-eu/eu-import-rules/eu-labeling-requirements/labeling-of-
genetically-modified-products/

Labeling regulations for genetically modified (GM) food products are established by Regulation
1829/2003 (articles 12-13). These rules apply to products that have undergone varying degrees of
processing. The regulation does not require labeling of food products that are not food ingredients, such
as processing aids. Meat, milk or eggs obtained from animals fed with GM feed or treated with GM
medicinal products do not require GM labeling. The traceability rules require all business operators to
transmit and retain information on GM products in order to identify both the supplier and the buyer of
the GM product.

Each individual genetically modified organism (GMO) must be approved before it can be used in food
and feed. The EU register of authorized GMOs can be consulted on the European Commission’s
website at http://ec.europa.eu/food/plant/gmo/eu_register/index_en.htm. All food products containing or
consisting of GMOs, produced from GMOs or containing ingredients produced from GMOs must be
labeled even if they no longer contain detectable traces of GMOs. The labeling requirement does not
apply to foods containing GMOs in a proportion equal to or less than 0.9 percent of the food ingredients
considered individually, provided their presence is adventitious or technically unavoidable. Above this
level, all products must be labeled using the following wording:

- Where the food consists of more than one ingredient, the words “genetically modified” or “produced
from genetically modified [name of ingredient]” must follow in brackets immediately after the
ingredient concerned. A compound ingredient with a GM component should be labeled “contains [name
of ingredient] produced from genetically modified [name of organism].”

Example: a biscuit containing soy flour derived from GM-soy must be labeled “contains soy flour from
genetically modified soy.”

- Where the ingredient is designated by the name of a category (e.g. vegetable oil), the words “contains
genetically modified [name of organism]” or “contains [name of ingredient] produced from genetically
modified [name of organism]” must be used.

Example: for vegetable oils containing rapeseed oil produced from genetically modified rapeseed, the
reference “contains rapeseed oil from genetically modified rapeseed” must appear in the list of
ingredients.

The designations may appear in a footnote to the ingredients list, provided they are printed in a font at
least the same size as that of the list of ingredients or, where there is no list of ingredients, clearly on the

31
labeling.

- Where there is no list of ingredients, the words “genetically modified” or “produced from genetically
modified [name of ingredient]” must appear clearly in the labeling.

Example 1: “a spirit containing caramel produced from genetically modified corn.”

Example 2: “genetically modified sweet corn.”

More information can be found on the European Commission’s website:

https://ec.europa.eu/food/plant/gmo/traceability_labelling_en and in the annual GAIN reports on
agricultural biotechnology.

Non-GMO: EU-harmonized legislation defining “non-GM,” ‘GM-free” or similar labeling terms does
not (yet) exist. National provisions and operator-specific “GM-free” and similar labeling schemes have
been developed in several Member States.

4. Organic Food Labeling

Council Regulation 834/2007 is the EU’s general framework regulation that sets out rules for organic
production and labeling. Commission Regulation 889/2008 sets out detailed rules for the
implementation of Regulation 834/2007. A new EU Regulation on organic production and labelling of
organic products has been adopted in May, 2018 and it will enter into force on January, 1, 2021,
repealing the Council Regulation 834/2007. For more information see GAIN report “New EU Organic
Regulations for Early 2018.”

The term “organic” and all its derivatives or diminutives such as “bio” and “eco” may be used only to
label products that comply with EU organic production rules and if at least 95% of the ingredients of
agricultural origin are organic. For products containing less than 95% organic ingredients, the term
“organic” may be used only to indicate individual organic ingredients in the list of ingredients. When
reference is made to the organic production method in the ingredients list, the total percentage of organic
ingredients must be indicated. The Annex to Regulation 834/2007 lists the term “organic” in all the
official EU languages.

For more information, see the European Commission’s website at

http://ec.europa.eu/agriculture/organic/index_en.

On July 1, 2012, the use of the EU organic logo became mandatory on all pre-packaged organic
products produced in the EU. Organic products imported from third countries may carry the EU organic
logo if they comply with the EU production rules. When the EU organic logo appears on the label, the
indication of the place of farming is required.

US-EU Equivalence Arrangement: The US-EU Organic Equivalence Arrangement took effect on June
1, 2012. The U.S. and EU have recognized each other’s organic production rules and control systems as
equivalent under their respective rules. Organic products certified to the USDA organic standards may
be sold and labeled as organic in the EU. Both the USDA organic seal and the EU organic logo may be
used on products traded under this Arrangement. When using the EU organic logo, exporters must meet

32
all the EU labeling requirements.

With the new EU Regulation on organic production adopted in May 2018, this equivalence arrangement
would expire by January 1, 2026, five years after the entry into force of the new regulation. By this
date, the U.S.-EU arrangement has to be converted to an organic trade agreement. If not, exporters will
have fully to comply with the exact same standards as the EU organic regulations to export to the EU.

For more information please see USDA Agricultural Marketing Service: National Organic Program
(International Trade Policies: European Union)

Commission Implementing Regulation 2016/1842 published on October 19, 2016, sets new rules for the
certification of EU organic food imports. Since October 19, 2017, only certificates initiated through the
EU’s Trade Control and Expert System (TRACES) are valid. For more information see GAIN report
“Electronic Certificate of Inspection Required for EU Organics Trade”.

Organic Wine: Commission Implementing Regulation 203/2012, applicable since August 1, 2012, sets
out specific rules for the production and labeling of organic wine. Only wines produced in accordance
with this regulation qualify as “organic wine” and can carry the EU organic logo. Labeling wine as
“made from organic grapes” is no longer allowed in the EU which means that U.S. wines labeled as such
cannot be imported into the EU. Sorbic acid and desulfurication are not allowed and the maximum
sulfite content may not exceed 100 mg per liter for red wine (150 mg per liter for conventional) and 150
mg per liter for white/rosé wines (200 mg per liter for conventional). In the United States, the addition
of sulfites is not allowed in organic wines. Commission Implementing Regulation 508/2012 only
authorizes imports of U.S. wines that are certified to comply with the EU’s organic wine rules.

New EU rules on organic food will apply from January 1, 2021

5. Wine, Beer and Other Alcoholic Beverages

Wine: The EU’s Single Common Market Organization (CMO) Regulation 1308/2013 establishes
framework rules for wine. Commission Regulation 607/2009 lays down detailed rules on protected
designations of origin and geographical indications, traditional terms and labeling.

Chapter III of Regulation 607/2009 sets out rules on the use of traditional terms. The “E-Bacchus”
database lists the traditional terms that are protected in the EU. The use of expressions such as “style,”
“type,” “method`’, “as produced in,” “imitation,” “flavor,” “like” or similar, in combination with a
traditional term included in the E-Bacchus database is not allowed. Non-EU countries need to obtain
authorization from the European Commission in order to use EU-protected traditional terms. To date,
the Commission has not made any progress on the U.S. applications, submitted in 2010, to use 11
traditional terms (Chateau, Clos, Ruby, Tawny, Crusted, Crusting, Noble, Solera, Sur lie, Vintage and
Vintage character).

In addition to the rules set out in the Single CMO, wine must also comply with the allergen labeling

33
rules established by the EU’s general labeling regulation 1169/2011. For detailed information on the
EU’s wine legislation, including labeling requirements, see GAIN report “EU Wine Policy” and the
European Commission’s website https://ec.europa.eu/agriculture/wine/legislation_en.

US-EU Wine Agreement: In March 2006, the U.S. and the EU and the U.S. signed the “Agreement
between the United States and the European Community on Trade in Wine”. The Agreement covers
wine with an actual alcohol content of not less than 7% and not more than 22%. All U.S. wine imports
must be accompanied by certification and analysis documentation using the format specified in Annex
III (a) to the Agreement. More information on the simplified EU import certificate form can be obtained
from the Alcohol and Tobacco Tax and Trade Bureau at
http://www.ttb.gov/agreements/us_ec_wine_agreement.shtml. The Agreement’s “Protocol on Wine
Labeling” sets conditions for the use of optional particulars on wine labels. Commission Regulation
1416/2006 concerns the protection of U.S. names of origin in the EU. Information on US-EU wine
trade can also be obtained from the U.S. Dept. of the Treasury - Alcohol and Tobacco Tax and Trade
Bureau at http://www.ttb.gov/importers/importing-exporting.shtml.

Spirit Drinks: European Parliament and Council Regulation 110/2008 lays down general rules on the
definition, description and presentation of spirit drinks. This regulation prohibits the use of the term
“spirit drink” as part of a compound term describing an alcoholic beverage.
Commission Implementing Regulation 716/2013 lays down rules for the application of Regulation
110/2008 as regards the use of compound terms and geographical indications of the spirit drinks. An
application to register “Tequila” as a geographical indication is currently going through the legislative
approval procedure.

In December 2016, the European Commission presented a proposal to replace the current spirit drinks
regulation 110/2008 with a new one. If adopted, the new regulation would introduce new procedures for
the management (applications, registrations, objections) of geographical indications. Annex III of the
existing regulation listing all the spirit drinks with a geographical indication would be deleted and
replaced with a publicly accessible updated electronic register of spirit drinks with a protected
geographical indication. The proposal is currently going through the legislative adoption procedure.

Commission Regulation 936/2009 applies the agreements between the EU and third countries on the
mutual recognition of certain spirit drinks. Under this regulation, “Tennessee Whisky” and “Bourbon
Whisky” are protected product designations.

Nominal Quantity: Mandatory nominal quantities for wines and spirits are set out in the Annex to
Directive 2007/45/EC.

Beer: There is no specific EU-harmonized legislation for beer. Some member states have adopted
national provisions to make the list of ingredients compulsory. All alcoholic beverages must comply
with the allergen labeling requirements.

Commission Report on Labeling of Alcoholic Beverages: The EU’s Food Information to Consumers
regulation 1169/2011 currently exempts alcoholic beverages from mandatory nutrition labeling and
ingredients listing but required the Commission to present a report assessing whether such labeling
should be introduced. Following the conclusions of the report, presented in March 2017, the

34
Commission invited the EU alcoholic beverages industry to come forward with a self-regulatory
proposal covering all sectors. In March 2018, EU industry presented a joint proposal outlining general
principles, accompanied by four sector-specific implementation plans: wine, spirit drinks, beer and
cider. For detailed information, see GAIN report “EU Alcohol Industry Labeling Proposal – Labeling
Apart Together” and the European Commission’s website
https://ec.europa.eu/food/safety/labelling_nutrition/labelling_legislation/alcohol_en.

Alcoholic beverages must comply with the EU’s allergen labeling rules set out in
FIC Regulation 1169/2011

6. Special Use Foods

http://www.usda-eu.org/trade-with-the-eu/eu-import-rules/eu-labeling-requirements/dietetic-foods/

On July 20, 2016, the EU’s revised “foods for specific groups” rules set out in European Parliament and
Council Regulation 609/2013 became applicable. Its scope is limited to infant formula, follow-on
formula, processed cereal-based food and baby food, food for special medical purposes and total diet
replacement for weight control. Pictures of infants are not allowed on the packaging of formula and no
text or pictures may idealize its use. Foods that no longer fall within the scope of Regulation 609/2013,
such as for example meal replacements and low calorie cereal bars are regarded as “normal” foods and
must comply with the EU’s horizontal food labeling rules. For more information see Section VI-E
“Dietetic Foods”.

As a rule, labeling requirements set out in the FIC regulation also apply to food categories covered under
regulation 609/2013. However, given the specific nature of the products covered, regulation 609/2013
introduces additional labeling requirements and derogations from the FIC regulation. For detailed
information on the new dietetic food rules see GAIN report “New EU Rules on Dietetic Foods”,
complemented by GAIN report “New EU Rules on Dietetic Foods – Update” and the Commission’s
website at http://ec.europa.eu/food/safety/labelling_nutrition/special_groups_food_en.

Food for sportspeople does not fall within the scope of regulation 609/2013. A Commission report on
food and beverages labeled specifically for sportspeople concluded that there is no need for specific EU-
harmonized provisions as existing horizontal EU food rules already provide an adequate legal
framework for these products. Before the adoption of regulation 609/2013, certain Member States
required the notification of sports food as a special use food. U.S. exporters should check with their
importers whether re-notification may be necessary. For more information see GAIN report “New EU
Rules for Sports Food”.

New EU rules on “total diet replacement for weight control” will become applicable on October 27,
2022. Commission Delegated Regulation 2017/1798 sets out specific compositional and labeling
requirements as well as a notification procedure under which food business operators are required to
send copies of their product labels to the competent authority of each Member State where the product

35
will be marketed. For more information see GAIN report “The Skinny on New EU Rules for Weight
Loss Products.”

Artificial sweeteners are not allowed in dietetic bakery products. For detailed information see GAIN
report “EU bans use of artificial sweeteners in dietetic bakery products.”

The use of artificial sweeteners is no longer allowed in dietetic bakery products.

7. Meat Labeling
http://www.usda-eu.org/trade-with-the-eu/eu-import-rules/eu-labeling-requirements/beef-labeling/

Beef

Regulation 1760/2000 sets out rules for compulsory and voluntary beef labeling. Detailed rules for the
implementation of Regulation 1760/2000 are set out in Regulation 1825/2000. Under the compulsory
beef labeling scheme, labels for all bovine meat must indicate the following information:

 “Born in: name of third country”

 “Reared in: name of third country or third countries”
 For beef derived from animals born, raised and slaughtered in the same third country, the above
indications may be combined as “Origin: name of third country”
 A reference number ensuring the link between the meat and the animal or animals
 “Slaughtered in: third country / approval number of slaughterhouse”
 “Cutting in: third country / approval number of cutting plant”
 A traceability code linking the meat to the animal or a group of animals representing the
production of maximum one day

Regulation 653/2014, an amendment to Regulation 1760/2000, changed the rules for voluntary labeling.
Voluntary beef labeling has to comply with the rules set out in the “Food Information to Consumers”
Regulation 1169/2011. Definitions and requirements applicable to terms and or categories of terms that
may be put on labels of pre-packed fresh and frozen beef and veal will be adopted at a later date.

Veal

Annex VII to European Parliament and Council Regulation 1308/2013 classifies bovine animals aged
less than 12 months in two categories: 1) “category V” - bovine animals aged 8 months or less and 2)
“category Z” - bovine animals aged more than 8 months but less than 12 months. For both categories,
Annex VII lists the sales descriptions in the different Member States languages and the mandatory

36
labeling requirements.

Pork, Sheep, Goats and Poultry

Commission Implementing Regulation 1337/2013 sets out new rules for the indication of the country or
place of provenance for fresh, chilled and frozen meat of swine, sheep, goats and poultry. The following
new labeling requirements became applicable on April 1, 2015:

1) The indication “Reared in: name of the Member State of third country” in accordance with the
following criteria:

For swine:

 In case the animal is slaughtered older than 6 months, the Member State or third country in
which the last rearing period of at least 4 months took place
 In case the animal is slaughtered younger than 6 months and with a live weight of at least 80 kg,
the Member State or third country in which the rearing period after the animal has reached 30 kg
took place
 In case the animal is slaughtered younger than 6 months and with a live weight less than 80 kg,
the Member State or third country in which the whole rearing took place

For sheep and goats:

 The Member State or third country in which the last rearing period of at least 6 months took
place, or in cases the animal is slaughtered younger than 6 months, the Member State or third
country in which the whole rearing period took place

For poultry:

 The Member State or third country in which the last rearing period of at least one month took
place or, in case the animal is slaughtered younger than one month, the Member State or third
country in which the whole rearing period after the animal was placed for fattening took place

In cases where any of the above rearing periods are not attained in any of the Member States or third
countries, the place of rearing must be indicated as “Reared in: several Member States of the EU” or
“Reared in: several non-EU countries” or “Reared in several EU and non-EU countries.” As an
alternative, the place of rearing may also be indicated as “Reared in: list of the Member States or third
countries where the animal was reared.”

The indication “Origin: name of Member State or third country” may be used in cases where the meat
has been obtained from animals born, reared AND slaughtered in one single Member State or third
country.

2) The indication “Slaughtered in: name of the Member State or third country.” By way of
derogation for meat imported from third countries, in cases where information on the rearing periods is
not available, the meat must be labeled as “Reared in: non-EU” and “Slaughtered in: name of the third

37
country where the animal was slaughtered.”

In October 2018, the European Commission published a roadmap to assess whether the rules on food
information to consumers as regards the mandatory origin labelling for pork, sheep, goats and poultry
are effective, efficient, coherent and relevant. This roadmap will be followed by a report that the
Commission needs to provide the European Parliament and Council with by April 1, 2020.

8. Health and Identification Marks

The EU’s “Food Hygiene Package” introduced new rules concerning the application of health and
identification marks. Chapter III of European Parliament and Council Regulation 854/2004 lays down
rules for applying a health mark to fresh meat. More information on the EU health mark is available on
USDA’s Food Safety Inspection Service’s website at
http://www.fsis.usda.gov/wps/portal/fsis/topics/international-affairs/exporting-products/export-library-
requirements-by-country/European-Union.

Annex II to European Parliament and Council Regulation 853/2004 lays down rules for applying an
identification mark to products of animal origin. Linear presentation of the required information is
allowed only for imports from EU-approved establishment in third countries.

9. Fish Labeling

Regulation 1379/2013 sets out labeling rules for fishery and aquaculture products listed in Annex I to
the regulation. Mandatory labeling information includes:

- Commercial designation of the species and its scientific name

- Production method

- Area where the products was caught or farmed

- Whether the product has been defrosted

- Date of minimum durability

For more information see the European Commission’s website

https://ec.europa.eu/fisheries/cfp/market/consumer-information_en.

10. Frozen Foodstuffs

Council Directive 89/108/EEC sets rules for quick-frozen foodstuffs and for their packaging and
labeling. Quick-frozen foodstuffs sold to the final consumer should carry the following additional
labeling indications: the product name with the indication “quick-frozen,” the date of minimum shelf
life, the period during which the purchaser may store the product, the storage temperature and/or type of
storage equipment required, batch identification and a clear indication of the type “do not re-freeze after
defrosting.” Annex VI, Part A, to FIC regulation 1169/2011 stipulates that foods that have been frozen

38
before sale and which are sold defrosted, the name of the food must be accompanied by the designation
“defrosted.”

For food of animal origin, Commission Regulation 16/2012 amending Food Hygiene Regulation
853/2004, requires food business operators to provide the date of production AND the date of freezing
to the buyers and upon request, to the competent authorities. Where a food is made from a batch of raw
materials with different dates of production and freezing, the older dates of production and/or freezing
must be made available.

Annex III to FIC regulation 1169/2011 requires that labels on frozen meat, frozen meat preparations and
frozen unprocessed fishery products indicate the date of freezing or the date of first freezing in cases
where the product has been frozen more than once.

Date of first freezing must be indicated when a product has been frozen more
than once

11. Vertical & Product-Specific Legislation

http://www.usda-eu.org/trade-with-the-eu/eu-import-rules/eu-labeling-requirements/

Vertical legislation on the manufacture and marketing of specific products has been developed for
sugars (Directive 2001/111), cocoa and chocolate products (Directive 2000/36), honey (Directive
2001/110), fruit juices and similar products (Directive 2001/112), preserved milk (Directive 2001/114),
coffee extracts and chicory extracts (Directive 1999/4) and fruit jams and similar products (Directive
2001/113).

Fruit Juices: Detailed information can be found in GAIN report “New EU Fruit Juice Labeling Rules”
published in May 2012.

Honey: On May 15, 2014, the EU adopted Directive 2014/63/EU amending Directive 2001/110/EC
relating to honey. It defines pollen as a natural constituent of honey and should not be considered to be
an ingredient of honey. This means that GM pollen present as a quantity of more than 0.9% of the
honey (not the pollen) would need to be labeled as such. Since pollen only forms around 0.5% of any
batch of honey, it will never exceed the GM labeling threshold.

Single Common Market Organization: European Parliament and Council Regulation 1308/2013
establishes a single common market organization (CMO) for all agricultural products. The single CMO
provides definitions and marketing rules for rice, sugar, beef and veal, milk and milk products, eggs and
poultry meat, olive oil, fruit and vegetables, spreadable fats and wine. In May 2018, the European
Commission published Delegated Regulation 2018/1096 on the requirements for certain indications on
the labelling of olive oil as regards the labeling of the maximum acidity and year of harvesting.

39
Section VI. Other Specific Standards

A. Novel Foods
http://www.usda-eu.org/trade-with-the-eu/eu-import-rules/novel-foods/

The EU’s new framework regulation 2015/2283 on Novel Food became applicable on January 1, 2018.
It defines novel food as food that has not been consumed to a significant degree in the EU before May
15, 1997 AND falling within at least one of the categories listed in Article 3 of the regulation (e.g.
cranberry extract powder). It can be a newly developed, innovative food resulting from new production
techniques (e.g. nanotechnology) as well as a traditional - but unknown to EU consumers - food from a
non-EU country (e.g. noni juice). The Novel Food regulation does not apply to GMO’s, additives,
enzymes, flavorings and extraction solvents. A guidance document on “human consumption to a
significant degree” is available on the European Commission’s website.

Authorization procedure: Novel foods require a pre-market authorization. Applications for

authorization must be submitted to the European Commission via an e-submission system. The
Commission may request the European Food Safety Authority (EFSA) to carry out a risk assessment.
An overview of the different steps of the authorization procedure is available on EFSA’s website.
Commission Implementing Regulation 2017/2469 sets out administrative and scientific requirements for
novel food applications. Authorizations are generic and no longer applicant-linked as was the case
under the previous rules.

EU Novel Food List: Commission Implementing Regulation 2017 2470 establishes a list of novel foods
authorized in the EU. Entries in the list include specifications, conditions of use, additional labeling
requirements and post-monitoring requirements.

Novel Food Status: Food business operators are responsible for verifying whether the food they intend
to market in the EU is novel or not. Novel Food regulation 2015/2283 provides for a consultation
process when the status of a food or food ingredient is unsure. Commission Implementing Regulation
2018/456 lists the procedural steps that food business operators must follow to consult with the
competent authority of the Member State where they first intend to market their product. A list of the
competent Member State authorities is available on the Commission’s website. For detailed information
see GAIN report “New EU Law on Novel Food Status Determination.”

Engineered nanomaterials: Engineered nanomaterials require a novel food authorization before being
used in food.

40
Food from clones: Until separate legislation on cloning is adopted, food from clones but not offspring
falls within the scope of the Novel Food regulation.

Traditional food from non-EU countries: Novel Food regulation 2015/2283 introduces a faster
notification and simplified assessment procedure for traditional foods with a demonstrated history of
safe food use from non-EU countries. Foods from non-EU countries which are considered novel foods
will only qualify as “traditional foods” if they are derived from primary production. For example, juice
derived from an exotic fruit not consumed in the EU before May 15, 1997 but part of a regular diet in a
non-EU country, would qualify as a ‘traditional food.” Commission Implementing Regulation
2017/2468 sets out administrative and scientific requirements for the notification of traditional foods
falling within the scope of the Novel Food regulation.

U.S. Exporters are advised to verify the legal status of novel food ingredients

B. Food from Animal Clones

http://www.usda-eu.org/topics/animal-cloning/

Food derived from cloned animals currently falls within the scope of the Novel Food Regulation 258/97.
Under this regulation, food produced by “new breeding practices” needs a pre-market approval based on
a risk assessment. In December 2013, under pressure of the European Parliament and the Council of the
EU, the European Commission proposed two pieces of specific legislation on food from cloned animals:
1) a proposal on the cloning of animals of the bovine, porcine, ovine, caprine and equine species kept
and reproduced for farming purposes and 2) a proposal to prohibit the placing on the market of food
from animal clones. To date, the European Parliament and the Council of the EU have not made any
progress on the cloning proposals. Until separate legislation is adopted, food from clones falls within
the scope of the Novel Foods regulation.

C. Nanotechnology
http://www.usda-eu.org/topics/nanotechnology/

Currently, EU legislation that explicitly addresses nanomaterials in food includes the following
regulations:

Food Information to Consumers (FIC): The presence of engineered nanomaterials in food products
must be clearly indicated on the label. The name of such ingredients must be followed by the word
“nano” in brackets (Art. 18 of Regulation 1169/2011).

Novel Food Regulation: Novel Food Regulation 2015/2283 defines engineered nanomaterials as “any
intentionally produced material that has one or more dimensions of the order of 100 nm or less or that is
composed of discrete functional parts, either internally or at the surface, many of which have one or
more dimensions of the order of 100 nm or less, including structures, agglomerates or aggregates, which
may have a size above the order of 100 nm but retain properties that are characteristic of the nanoscale”
(Article 3.2.f).

41
Food Additives:- Regulation 1333/2008 states that when “there is a significant change in the production
methods or in the starting materials used” for food additives already on the Community list of approved
food additives, “or there is a change in particle size, for example through nanotechnology, the food
additive prepared by those new methods or materials shall be considered as a different additive and a
new entry in the Community lists or a change in the specifications shall be required before it can be
placed on the market.”

Food Contact materials – Regulation 450/2009 on active and intelligent packaging states that “new
technologies to engineer substances with different chemical and physical properties than the same
substances at a larger scale, for example nanoparticles, should be assessed at a case-by-case basis as
regards their risk until more information is known about such new technology.”

For more information on nanotechnology in the EU see:

- FoodDrinkEurope: http://www.fooddrinkeurope.eu/our-actions/topic/nanotechnology/eu-
projects/
- European Food Safety Authority: new guidance on nanotechnologies in food and feed (published
July 2018)
- EU Science Hub: https://ec.europa.eu/jrc/en/research-topic/nanotechnology

D. Fortified Foods
http://www.usda-eu.org/trade-with-the-eu/eu-import-rules/eu-labeling-requirements/fortified-foods/

European Parliament and Council Regulation 1925/2006 established an EU-wide regulatory framework
for the addition of vitamins and mineral and of certain other substances such as herbal extracts to foods.
It lists the vitamins and minerals that may be added to foods and sets criteria for setting maximum and
minimum levels. A European Commission proposal setting harmonized maximum and minimum
permitted levels of vitamins and minerals in foods and food supplements is already ten years overdue
(original deadline set by Regulation 1925/2006 was January 2009). Vitamins and minerals must be
expressed as a percentage of the “Reference Intakes” listed in Annex III to the “Food Information to
Consumers” regulation 1169/2011 (see also Section V “Nutrition Declaration.” The use of vitamins and
minerals not included in the annexes to Regulation 1925/2006 is not allowed. A “Community Register”
on the addition of vitamins and minerals and of certain other substances is available on the European
Commission’s website at https://ec.europa.eu/food/sites/food/files/safety/docs/labelling_nutrition-
vitamins_minerals-comm_reg_en.pdf.

Maximum permitted levels of vitamins and minerals in foods and food

supplements are not yet EU harmonized

42
E. Dietetic Foods
http://www.usda-eu.org/trade-with-the-eu/eu-import-rules/eu-labeling-requirements/dietetic-foods/

Regulation 609/2013, applicable since July 20, 2016, sets out compositional and labeling rules for foods
for specific nutritional uses. Its scope is limited to infant formula and follow-on formula, processed
cereal-based food and baby food, food for special medical purposes and total diet replacement for
weight control. Dietetic foods, e.g. gluten-free foods, not covered by Regulation 609/2013 are
considered regular foods (see also Section V “Special Use Foods”) and must comply with the rules set
out in Food Information to Consumers regulation 1169/2011, regulation 1925/2006 on the addition of
vitamins and minerals to food and with regulation 1924/2006 on nutrition and health claims.

Commission Delegated Regulation 2016/128 sets out specific requirements for food for special medical
purposes (FSMPs).

Commission Delegated Regulation 2016/127 sets out specific compositional and information
requirements for infant-formula and follow-on formula.

Commission Delegated Regulation 2018/561 details the protein requirements for follow-on formula.

Commission Delegated Regulation 2017/1798 sets out new rules for “total diet replacements for weight
control”. The new rules will become applicable on October 27, 2022. For detailed information see
GAIN report “The Skinny on New EU Rules for Weight Loss Products.”

Commission Regulation 2018/97 bans the use of artificial sweeteners in fine bakery products. For more
information, see GAIN report “EU bans use of artificial sweeteners in dietetic bakery products.”

New rules on the reduction of acrylamide levels in food, set out in Commission Regulation 2017/2158,
became applicable on April 11, 2018. The new rules also apply to baby food and processed cereal-based
food intended for infants and young children.

U.S. Exporters of dietetic products should verify whether the products fall
within the scope of Regulation 609/2013

F. Food Supplements
http://www.usda-eu.org/trade-with-the-eu/eu-import-rules/food-supplements/

EU Directive 2002/46/EC only sets out EU-harmonized rules on labeling and vitamins and minerals that
may be used in food supplements. Key aspects in the marketing of food supplements such as minimum
and maximum levels of vitamins and minerals or the use of other substances such as botanical extracts
remain the competence of the Member States. Directive 2002/46 defines food supplements as food
which means that all exports of food supplements must not only comply with Directive 2002/46 but also
with horizontal rules applicable to all foods including rules on additives, novel foods, hygiene,
contaminants and GMOs. U.S. exporters of whey protein supplements should work with their importers

43
to determine whether their product should be accompanied by a certificate for processed dairy products
or one for composite products. For more information see GAIN report “Certification and Labeling of
EU Whey Protein Supplements.” Marketing food supplements in the EU is a very complex issue.
GAIN report “Exporting Food Supplements to the EU” provides detailed information on marketing food
supplements in the EU.

G. Irradiated Foodstuffs

Harmonization of EU rules on food irradiation has been slow and only a few products have so far
received EU-wide approval. Framework Directive 1999/2/EC outlines the marketing, labeling, import
and control procedures and technical aspects of food irradiation. Irradiated foods or foods containing
irradiated ingredients must be labeled "irradiated" or "treated with ionizing radiation.” For more
information, see the European Commission’s website at
http://ec.europa.eu/food/safety/biosafety/irradiation_en. The European Commission is currently
assessing whether the rules should be updated in light of technical progress,

H. Seafood

Detailed information on shipping seafood and fishery products to the EU is provided in the U.S.
Department of Commerce’s exporter guide “Exporting Seafood to the European Union – December
2017 Update”. Information on mandatory EU labeling requirements as well as reports on the feasibility
of an EU eco-label can be found in the European Commission’s Fisheries website
https://ec.europa.eu/fisheries/cfp/market/consumer-information_en.

I. Pet Food
http://www.usda-eu.org/trade-with-the-eu/eu-import-rules/pet-food/

In the EU, pet food is subject to feed marketing legislation and veterinary legislation. The EU’s feed
marketing legislation covers food for pets as well as feed for food-producing animals. The veterinary
legislation covers products of animal origin and hay/straw as these products present a risk for spreading
animal diseases. Pet food products containing an animal origin ingredient must be sourced from
approved establishments and have to be accompanied by a veterinary certificate. All exports of U.S. pet
food to the EU must comply with EU requirements including rules on labeling, hygiene, animal health,
certification and the use of additives. GAIN report “Exporting Pet Food to the European Union”,
updated in January 2018, provides a detailed overview of EU legislation relating to imports of pet food.

European Parliament and Council Regulation 767/2009 sets out rules for the labeling and marketing of
feed and pet food. It covers feed materials, compound feed and medicated or dietetic feed for both food
and non-food producing animals. For more information, see GAIN report “EU Feed and Pet Food
Labeling Requirements.” Feed and pet food not complying with Regulation 767/2009 and with the
provisions on feed additives laid down in Regulation 1831/2003 will not be allowed on the EU market.
Conditions for mixing veterinary medicine into feed are set out in Directive 90/167/EEC. In September
2014, the European Commission presented a proposal to replace the outdated Directive 90/167/EEC on
medicated feed. The scope of the proposal explicitly includes medicated feed for pets. The proposal is

44
expected to be adopted by the end of 2018. For more information see the Commission’s website
https://ec.europa.eu/food/safety/animal-feed/medicated-feed_en. EU border inspection officials will
verify the labels on imported pet food for compliance with EU requirements. Annex 4 to the “Code of
Good Labeling Practice for Pet Food,” drafted by the European Pet Food Industry (FEDIAF) establishes
a “check-list” that pet food manufacturers can use to verify compliance with EU labeling rules.

Commission Regulation 68/2013 establishes a catalogue of feed materials. It enables operators to use
more precise names and expressions for the feed they place on the market. The annex to the Catalogue
contains three parts: A) general provision, B) glossary of processes and C) list of feed materials. The
use of the Catalog is voluntary but where it is used all relevant provisions have to be complied with.

Commission Recommendation 2011/25/EU established guidelines for the distinction between feed
materials, feed additives, biocidal products and veterinary medicinal products.

For more information on animal nutrition, see the European Commission website at
http://ec.europa.eu/food/safety/animal-feed_en.

J. Vegetarian & Vegan Foods

The Food Information to Consumers (FIC) regulation 1169/2011 requires the European Commission to
set out rules for the voluntary labeling of foods as “suitable for vegetarians and vegans.” To date, the
Commission has not adopted an EU-harmonized definition of the terms “vegetarian” and “vegan.” In
the absence of EU-harmonized rules, food companies have started using the “European V-label,” a
labeling scheme launched by umbrella organization the European Vegetarian Union (EVU). For more
information, see EVU’s website at http://v-label.eu/about-v-label.

In July 2017, the European Court of Justice (ECJ) ruled that plant-based products cannot be labeled with
dairy names such as “cheese,” “butter” or “milk”. The ECJ based its ruling on Regulation 1308/2013
setting out definitions and designations that may only be used for the marketing of dairy products. A list
of exceptions for non-dairy products that may be labeled with reserved dairy names was established by
Commission Decision 2010/791. For more information see GAIN report E17046 on the ECJ ruling.

Section VII. Facility and Product Registration

A. Facility Registration
http://www.usda-eu.org/trade-with-the-eu/eu-import-rules/certification/approved-u-s-establishments/

The EU approves establishments to ship products of animal origin based on submissions from U.S.
government agencies. Only products processed in approved establishments may enter the EU. Detailed
information on approved U.S. establishments is available on our website at http://www.usda-
eu.org/trade-with-the-eu/eu-import-rules/certification/. Third country lists per sector and per country
are published on the European Commission’s website

45
https://webgate.ec.europa.eu/sanco/traces/output/non_eu_listsPerCountry_en.htm.

B. Product Registration

U.S. exporters should be aware that certain products and ingredients may fall within the scope of the
Novel Foods Regulation and need a pre-market authorization. Detailed information is provided in
Section VI “Other Specific Standards.”

Certain foods, such as total diet replacements for weight control, falling within the scope of the EU’s
Foods for Specific Groups Regulation 609/2013 must be notified to the competent authority of the
Member State where the food is marketed.

Exporters of vitamin-enriched foods or nutritional supplements are especially advised to check for
the existence of specific Member State registration or notification requirements. A list of the competent
Member State authorities is available on the European Commission’s website at
https://ec.europa.eu/food/sites/food/files/safety/docs/labelling_nutrition-supplements-
food_supplements_authorities_en.pdf. More information is also available at
https://ec.europa.eu/food/safety/labelling_nutrition/vitamins_minerals_en.

Section VIII. Other Certification and Testing Requirements

A. Certification and Documentation Requirements
http://www.usda-eu.org/trade-with-the-eu/eu-import-rules/certification/

An overview of all U.S. authorities that issue the legally required certificates for export to the EU is
available on our website at https://www.usda-eu.org/trade-with-the-eu/eu-import-rules/certification/u-s-
agencies-providing-eu-certificates/. The websites of each of those authorities provide detailed and up-
to-date information on the specific product certificates under their legal authority.

Composite Products: U.S. exports of “composite products” are continuing to be restricted due to
burdensome certification requirements introduced in a 2012 European Commission Regulation.

46
Composite products are defined as foodstuffs intended for human consumption that contain processed
products of animal origin and ingredients of plant origin. Composite products include a wide variety of
products, including cheesecakes, high protein food supplements, pizza, and lasagnas. While the U.S. is
eligible to ship hormone-free meat, dairy products, egg products, and fishery products separately, it is
often no longer possible to ship the composite products that combine these eligible ingredients.

All composite products containing a processed meat product are subject to a veterinary check. Generally
speaking, composite products that contain more than 50 percent of animal origin products also require a
certificate, and there are certification requirements concerning the heat treatment for all dairy products.
The components of animal origin (except gelatin and collagen) used for producing a composite product
have to originate from a third country with an approved residue control plan for the specific component.
The EU has created a model health certificate for imports of composite products, which was
implemented in 2012. A detailed “Product Decision Tree” to clarify the scope of the legislation was
made available by the European Commission in 2013. This guidance greatly expanded the number and
types of products affected by the legislation. The decision tree is included in the further guidance that
was developed and published in 2015 to address a wide range of implementation questions related to the
import and transit of composite products. For more information, see http://www.usda-eu.org/trade-with-
the-eu/eu-import-rules/certification/.

B. Inspections

Member State authorities are responsible for carrying out inspections on a regular basis and in cases
where non-compliance is suspected. Products can be checked at import or at all further stages of
marketing. Infringements of EU food and feed legislation are reported through the Rapid Alert System
on Food and Feeds (RASFF). The rapid alert system is a network of Member State authorities managed
by the European Commission. The database with RASFF notifications is accessible via the RASFF
portal. Information published on this website provides several notification details such as the reason for
the non-compliance and the origin of the product but does not include company information. Repeated
non-compliance may lead to suspension of imports or special import conditions for products from the
third country concerned, applicable on the entire EU territory.

Criteria for laboratories conducting food controls have been harmonized but it is the Member States’
responsibility to designate laboratories that are allowed to perform analyses.

Specific detailed inspection requirements exist for animal products (Directive 97/78/EC). Products of
animal origin must be presented at a Community border inspection post and submitted to an import
control following prior notification of the shipment. Commission Decision 2009/821/EC establishes a
list of EU border inspection posts approved to carry out veterinary checks on animals and animal
products from third countries. Commission Decision 2007/275/EC establishes a list of animals and
products that are subject to controls at border inspection posts, including certain composite products as
well as a list of composite products that are not subject to veterinary checks.

European Parliament and Council Regulation 854/2004 lays down specific rules for the organization of
official controls on products of animal origin. European Parliament and Council Regulation 882/2004
lays down general rules for the performance of official controls to ensure the verification of compliance

47
with feed and food law, animal health and animal welfare rules. Commission Regulation 669/2009
implements Regulation 882/2004 as regards the increased level of official controls on imports of certain
feed and food of non-animal origin. Regulations 854/2004 and 882/2004 will be repealed by European
Parliament and Council Regulation 2017/625 on December 14, 2019. An overview of the main
elements and changes introduced by the new regulation on official controls is available on the
Commission’s website https://ec.europa.eu/food/safety/official_controls/legislation_en.

Product samples destined for human consumption have to comply with the food regulations applicable
in the EU. In order to send product samples to commercial trade shows, it is advised to take contact
with the FAS office in the Member State where the trade shows takes place. Please also contact our
Member State FAS office or the EU APHIS office (Xavier.Mennig@aphis.usda.gov) for export of food
samples for technical or research purposes.

Inspection fees for non-animal origin products differ from one Member State to another. Measures in
case of non-compliance also vary widely, ranging from non-admittance of a product to forced
destruction. This may be a decisive factor in choosing a port of entry for products where problems are
more likely.

An overview of sanitary and phytosanitary requirements is also available on the European Commission
websites: DG Health and Consumers “International Affairs – Import Conditions” and DG Trade “Trade
Helpdesk”.

Section IX. Import Procedures

A. Union Customs Code

The “Union Customs Code” (UCC) established in European Parliament and Council Regulation
952/2013 is the framework regulation on rules and procedures for customs throughout the EU.
Implementing provisions were published in Official Journal L 343 on December 29, 2015: Commission
Delegated Regulation 2015/2446 and Commission Implementing Regulation 2015/2447 lay down
detailed rules for the implementation of certain provision of the new UCC including Binding Tariff
Information and origin of goods. The UCC along with the implementing provisions became applicable
on May 1, 2016, but further changes will be phased in up to December 31, 2020.

The Code lists all the customs procedures applicable to the trade in goods with third countries. Import
duties are determined by the tariff classification of goods and by the customs value. With the
implementation of the Code, the Member States of the European Union form a customs union, which
means that all the Member States apply the same tariff on goods imported from outside the EU. Once an
imported good is cleared in one Member State, it can move freely throughout the EU. All traders
involved in customs transactions have to provide EU customs authorities with security data on goods

48
before they are imported into the EU. The type of security data requested varies according to the means
of transport and can include a description of the goods, information on the consignor or exporter, the
route of the goods and any potential hazards. The time limits for submitting advance security data also
vary according to the means of transport. A guidance document on “Customs formalities on entry and
import into the European Union” is available on DG Taxud’s website.

On October 2, 2017, the European Commission launched the “Customs Decisions System”, a new pan-
EU electronic system that make it easier for traders to get permission to import goods into the EU.
Importers in all the Member States are able to use the same portal and exchange applications between all
the relevant customs authorities.

A complete overview of the EU’s UCC is available on the European Commission’s DG for Taxation and
Customs Union (TAXUD) website.

Further changes to the EU’s new Union Customs Code will be phased in B.
Cust
up to December 2020
oms
Clearance

The European Commission’s “Trade Helpdesk” provides a complete overview of documents needed for
customs clearance: http://trade.ec.europa.eu/tradehelp/.

C. Import Duties

The EU uses the Combined Nomenclature (CN) for the customs classification of goods. The CN eight
digit code numbers are based on the Harmonized System (HS) nomenclature: the first six digits refer to
the HS headings; the two following digits represent the CN subheadings. The EU’s on-line “TARIC”
customs database can be consulted to look up commodity codes and relevant import duties. TARIC is a
multilingual database covering all measures relating to tariff and trade legislation. The EU’s 2019 Tariff
Schedule was published on October 31, 2018 in Official Journal L273. A list of Member State customs
authorities can be found at https://ec.europa.eu/taxation_customs/national-customs-websites_en.

Business operators can obtain Binding Tariff Information (BTI) from a Member State’s customs
authority in order to get the proper product classification and relevant import duty. A BTI decision is
legally binding in all the Member States. A BTI is valid for three years. U.S. exporters should be aware
that the UCC makes the declaration of a BTI decision mandatory when completing customs formalities.
All BTI decisions issued by the Member States’ customs authorities are entered into an EBTI-database.
Administrative guidelines on the new BTI-system are published on DG Taxud’s website. The customs
value of a good is the CIF price at the European border derived from the product price found on the
invoice and the transportation costs reflected in the airway bill or the bill of lading.

Commission Regulation 900/2008 lays down analytical methods and other technical provisions to
calculate the starch/glucose and sucrose/invert sugar/isoglucose content in processed products. These
calculations are used to determine the additional duties on flour and sugar in processed products.

49
Goods are only released after payment of the import duty and other taxes that may be due.

Duties payable on goods imported into the EU may include:

 import duty (expressed as ad valorem tariffs or specific tariffs per unit weight/volume/number of
pieces) – EU harmonized

 additional duties on flour and sugar (processed products) – EU harmonized

 entry price (fruit and vegetables) – EU harmonized

 environmental taxes - not harmonized

 inspection fees - not harmonized

 Value Added Tax (VAT) - not harmonized

 excise duties (alcohol and tobacco) - not harmonized

A list of VAT rates applicable in the different Member States can be found at:
http://ec.europa.eu/taxation_customs/resources/documents/taxation/vat/how_vat_works/rates/vat_rates_
en.pdf.

A list of excise duties applicable on alcoholic beverages and tobacco can be found at:
http://ec.europa.eu/taxation_customs/taxation/excise_duties/index_en.htm.

Council Directive 92/83/EEC harmonizes the structures of excise duties on alcohol and alcoholic
beverages and establishes common definitions of alcoholic products that are subject to excise duties as
well as exemptions. The excise legislation also sets down the minimum rates of tax that must be applied
for each category; however, Member States have the freedom to set rates at a higher level. In May 2018,
the European Commission proposed a new text amending Directive 92/83/EEC. If adopted, the new
Directive would inter alia change the definition of “cider” and apply reduced rates to some independent
small maker of alcoholic drinks.

50
Section X. Copyright and/or Trademark Laws

A. Trademarks

In the EU, trademarks can be registered at the national, regional or EU level. Trademarks registered at
the national level are protected in one EU Member State. Applications must be submitted directly to the
relevant national IP-office (full list of national offices). Currently, there is only one regional-level IP
office in the EU, i.e. the Benelux Office which registers trademarks for three Member States: Belgium,
the Netherlands and Luxembourg. Applications for the protection of a trademark in all EU Member
States must be submitted to the European Union Intellectual Property Office (EUIPO). An online
application costs 850 EUR. Full details on the registration process are available on the EUIPO website.
Rules on the protection of trademarks in the EU are set in EU Directive 2015/2436. Commission
Implementing Regulation 2018/626 sets out detailed rules on application procedures. Commission
Delegated Regulation 2018/625 sets out procedural rules on opposition and revocation of EU
trademarks.

B. Protected Geographical Indications

http://www.usda-eu.org/topics/geographical-indications/

Several food product names considered as generic in the U.S. such as for example feta, parmesan and
Parma ham, are protected under EU law. European Parliament and Council Regulation 1151/2012,

51
applicable since January 4, 2016, sets out rules on optional quality terms such as “mountain product”
and regulates three EU-wide quality labeling schemes. It covers the “Protected Designation of Origin”
(PDO) scheme, the “Protected Geographical Indication” (PGI) scheme and the “Traditional Specialties
Guaranteed” (TSG) scheme. Registration under the different schemes is also open to non-EU countries.
Wines and spirits are covered by specific legislation and do not fall within the scope of regulation
1151/2012. In July 2018, the European Commission presented a proposal on EU accession to the
“Geneva Act of the Lisbon Agreement on Appellations of Origin and Geographical Indications.”
Membership would enable the EU to obtain protection for its GI’s in all the contracting parties to the
Lisbon Agreement. For more information see GAIN report “EU Prepares to Join Lisbon Agreement on
Geographical Indications.”

The European Commission’s website provides guidance on how to register a PDO/PGI or how to object
to a PDO/PGI proposed for registration. Lists of protected names by country, product type, registered
name and name applied for are available through the Commission’s online “DOOR” (Database of Origin
and Registration) database.

“Protected Designation of Origin” (PDO) is defined as follows:

- Originating in a specific place, region or in exceptional cases, a country

- Quality and characteristics of the product are essentially or exclusively due to a particular
geographical environment with its inherent natural and human factors

- ALL of the production steps take place in the defined geographical area

Example of a PDO: Prosciutto di Parma (Parma ham)

“Protected Geographical Indication” (PGI) is defined as follows:

- Originating in a specific place, region or country

- Quality, reputation or other characteristics are essentially attributable to the geographical origin

- At least one of the production steps takes place in the defined geographical area

Example of a PGI: Gouda Holland

“Traditional Specialties Guaranteed” (TSG):

The TSG quality label is used to communicate the value-added characteristics of traditional recipes and
traditional production methods to consumers. “Traditional” is defined as a proven usage of at least 30
years. Unlike the PDO and PGI schemes, the geographical origin of a product is irrelevant under the
TSG scheme. Under the new rules, TSGs are included a Community Register with name reservation.
Only products complying with the TSG specifications can use the registered name.

Example of a TSG: Mozzarella

52
Detailed information on the TSG scheme is available in GAIN report “The EU’s Traditional Specialties
Guaranteed Scheme Explained”.

Optional Quality Terms:

Regulation 1151/2012 sets out criteria for the use of optional quality terms. The European Commission
is empowered to reserve new terms or amend the conditions of use of existing terms.

Example of an optional quality term: Mountain Product

APPENDIX I. GOVERNMENT REGULATORY AGENCY CONTACTS

European Commission
Rue de la Loi 200
1049 Brussels
Belgium
Tel: (32-2) 299 1111

European Union Intellectual Property Office (EUIPO)

Avenida de Europa, 4
E-03009 Alicante
Spain
Tel: (34-96)513 91 00
E-mail: information@euipo.europea.eu
Website: https://euipo.europa.eu

European Union - Delegation of the European Commission to the United States

2300 M Street
NW, Washington, DC 20037
Tel: (202) 862-9500
Fax: (202) 429-1766
E-mail: delegation-usa-info@eeas.europa.eu
Website: https://eeas.europa.eu/delegations/united-states-america_en

United States Mission to the European Union

Office of Agricultural Affairs
Mailing address:
27 Boulevard du Regent

53
1000 Brussels
Belgium
Tel: (32-2)811-5793
Fax: (32) (2) 811-5560
E-mail: AgUSEUBrussels@fas.usda.gov
Website: www.usda-eu.org

Animal and Plant Health Inspection Service

Mailing Address:
27 Boulevard du Regent
1000 Brussels
Belgium
Listing of APHIS-Brussels Staff:
https://www.aphis.usda.gov/aphis/ourfocus/internationalservices/offices/contact_us_pages/contact_us_b
russels_belgium

National Oceanic & Atmospheric Administration (NOAA) Representative to the EU:

Mailing address:
27 Boulevard du Regent
1000 Brussels
Belgium
Tel: (32-2)811-5831
E-mail: Stephane.Vrignaud@trade.gov

Food and Drug Administration (FDA)

Mailing address:
27 Boulevard du Regent
1000 Brussels
Belgium
Tel: (32-2)8114518
E-mail: US-FDA-EUR@fda.hhs.gov

Other FAS Offices in the European Union:

https://www.fas.usda.gov/content/contact-us-0

FDA contacts for certification of animal products:

http://www.fda.gov/AnimalVeterinary/Products/ImportExports/default.htm

Food Safety & Inspection Service (FSIS) Export Requirements for the EU:
http://www.fsis.usda.gov/wps/portal/fsis/topics/international-affairs/exporting-products

Animal & Plant Health Inspection Service (APHIS) – Import & Export:
http://www.aphis.usda.gov/import_export/index.shtml

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APPENDIX II. OTHER IMPORT SPECIALIST CONTACTS

U.S. MISSION TO THE EU – FAS ORGANIZATIONAL CHART

Email: firstname.lastname@fas.usda.gov
http://www.usda-eu.org/contact-fas/

Bruce Zanin, Minister-Counselor for Agricultural Affairs

Anthony Gilbert Jennifer Lappin Lisa Allen

Senior Agricultural Agricultural Attaché Agricultural Attaché
Attaché
Bilateral Coverage Biotechnology & New Breeding Techniques Dairy, Livestock & Poultry
(Belgium) Grains & Feed Veterinary Equivalency Agreement
TTIP Oilseeds & Products PRT’s
Renewable Energy Organic Products GE Animals
Directive Biofuels Animal Products
WTO Forest Products Horticultural Products
EU Food & Agriculture Food & Feed Additives Endocrine Disruptors
Policy Sustainability Pesticides/Contaminants
Brexit Wines & Spirits Certification
Third Country Food and Drink Labeling incl. COOL/GIs Sugar
Agreements Novel Foods CSSF
CSS Website Management
Budget & Administration
ICASS

LOCAL STAFF

Barrie Williams Antonella Rossetti Tania De Belder

Agricultural Specialist Agricultural Specialist Agricultural Specialist

55
European Parliament European Parliament Relations New Breeding Techniques
Relations EU Decision-Making Procedures Pesticides
Agriculture & Fisheries Sustainability/Climate Change/Environment Endocrine Disruptors
Council/EU Presidency Organics and Environmental Issues Food & Feed Additives
PermRep Relations CAP: Rural Development Nanotechnology
Biotechnology Forest Products Packaging Materials
CAP EU Procedures Horticultural Products
Grains & Feed Wine and Spirits WTO SPS & TBT Notifications
EU Budget EU Food Quality Schemes Bilateral Relations & Marketing
Risk Analysis Geographical Indications and Country of (Belgium)
Brexit origin labeling (COOL)
Sophie Bolla Yvan Polet
Agricultural Specialist Agricultural Specialist
EU Food Law Dairy, Livestock & Poultry
Novel Foods Animal Welfare
Food and Drink Labeling Animal Health
Dietetic Foods & Food Animal Cloning
Supplements GE Animals
Agriculture & Fisheries WTO (Market Access, Domestic Support, Export
Council/EU Presidency Competition)
Dual Quality Foods Sugar
Pet Food Belgian Farm Organizations
Export Promotion EU Consolidated Reporting (Belgium)
Programs
Retail Report Belgium
Oilseeds & Products
Biofuels
Website Management

Gerda Vandercammen
Agricultural Specialist
EU Food & Feed Import Controls
EU General Food Law / Food Hygiene
EU Food Safety Policies
Contaminants
Certification/TRACES
Risk Analysis
CODEX
Bilateral Port Issues (Belgium)

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